Study Description:Currently, many Americans suffer from asthma. The exact mechanism by which airway inflammation leads to asthma symptoms has yet to be clearly explained. In previous studies, persons with asthma appear to have different types of inflammation in their lungs. The reasons for this difference remain a mystery. Allergy is known to play a role in the constriction of the muscle in the airways (bronchospasm). Other mechanisms have not been discovered. The purpose of this study is to determine how heartburn may lead to different types of inflammation in one’s airways. Additionally, we hope to determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by biopsy. The results of this study will be important in directing future research into the relationship between heartburn and asthma and may provide a clue whether certain subtypes of asthma may be caused primarily by GER. Key search words (disease/condition specific):Asthma, gastroesophageal reflux, pulmonary inflammation Who is Eligible to participate in the Study?
- Age Range: 18-65
- Inclusion Criteria
1. Moderate asthmatic
2. Complaints of gastroesophageal reflux
1. Severe asthmatics who have been hospitalized within the last 6 months or who have required oral steroid use within the last 4 weeks
2. Severe coronary artery disease
3. Cigarette/cigar smoking within the last 6 months
4. Documented allergies affecting the respiratory system
5. Subjects with contraindications to pH/impedance probe
a. Hemophilia
b. Septal deviation
6. Subjects with contraindications to bronchoscopy as outlined by the American Thoracic Society Guidelines
7. Anticoagulation
8. Pregnancy
9. Incarcerated patients
10. Current oral steroid use (may suppress levels of inflammation)
11. Upper respiratory infection within the last 2 weeks
12. Ongoing acid suppression with a proton pump inhibitor, however, patients may be included if they have discontinued their proton pump inhibitor within the last 1 month with stable asthma symptoms as defined by stable utilization of inhaled steroids
How long will the Study run?The study enrollment period will be about a year. Participants will be in the study for approximately 4 months. What is/are the Locations of this Clinical Trial? University of Utah, Division of Gastroenterology Who can I Contact for Additional Information on this Trial?
A Phase IIIb Multi-Center, Double-Blind, Placebo-Controlled, Randomized Trial to Examine the Corticosteroid-Sparing Effect of Certolizumab Pegol in Patients with Moderate to Severe Crohn’s Disease (COSPAR I)
Principal Investigator: Christopher Tietze, M.D., Ph.D.
IRB Approval Number: 20541
Study Status: Waiting IRB approval Study Description: Certolizumab pegol is an investigational into-TNF a agent. It is an engineered, humanized monoclonal antibody Fab' fragment that is manufactured in E coli, subsequently purified and conjugated to polyethylene glycol. It is intended for subcutaneous administration. The engineered Fab' fragment retains the biologic potency of the original antibody. It binds to human TNF a with high affinity, thus neutralizing its biological activity. Certolizumab pegol does not lyse cells that express high levels of membrane-bound TNF a. The site-specific polyethylene glycolation increases the half-life of the antibody fragment to approximately 2 weeks in plasma, thereby reducing the frequency of required dosing.
The purpose of the present study is to assess the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have received initial acute therapy with prednisone to prednisolone for induction of remission. During double-blind study treatment, patient will be tapered off the corticosteroids according to a standard schedule, which will allow complete steroid withdrawal in 8-10 weeks. Patients who are successfully tapered and discontinued from the corticosteroid will continue to receive double-blind treatment through Week 36 and the maintenance of remission will be followed through Week 38 of the study.
Key search words (disease/condition specific):Crohn’s Disease, certolizumab pegol, TNF a Who is Eligible to participate in the Study?
Inclusion Criteria
- Patient is able to understand the information provided to them and who have given written informed consent to the study
- Patient is able to understand and complete self-administered questionnaires
- Men and women, age 18 years or older
- A diagnosis of moderate to severe Crohn's disease (CDAI of > 200- <450) during the run-in period
- The patient is a candidate for treatment with prednisone or prednisolone therapy, but is not on maintenance corticosteroid therapy
- If the patient is on an immunosuppressant (azathioprine, 6-mercaptopurine, and methotrexate are allowed immunosuppressant), the dose has to have been stable for at least 8 weeks prior to screening and is expected to remain stable during the study
- If the patient is on a 5-ASA analogue for Crohn's disease, the dose has to have been stable for at least 4 weeks prior to screening and is expected to remain stable during the study.
- If female, the patient is either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or perineal hormonal contraceptive; intrauterine device; barrier and spermicidal—abstinence is not an acceptable method). Patients must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab
Crohn’s Disease Related
- Prior treatment with anti-TNF a therapy, including certolizumab pegol
- Active or draining fistula present at screening
- On maintenance corticosteroid therapy
- Symptomatic obstructive intestinal strictures
- Functional colostomy or ileostomy (patients who have a temporary stoma in the past, which as been reversed, are eligible to enter the study)
- Bowel resection within 3 months of starting the study medication
- Current total parenteral nutrition
- Short bowel syndrome
- Positive stool laboratory results for pathogens
- Antibiotic treatment for Crohn's disease within 2 weeks prior to screening.
Medical History related
- Ulcerative colitis
- Irritable bowel syndrome
- Other autoimmune disease (e.g. rheumatoid arthritis, lupus erythematosus)
- Lactating and/or pregnant female patients
- If female, a positive serum pregnancy test at screening or a positive urine pregnancy test prior to dosing
- A history of tuberculosis (TB) or positive PPD skin test (defined as positive induration of >5 mm). patients with a positive PPD skin test who have received BCG vaccination and have a negative chest X-ray for TB may be enrolled the discretion of the investigator
- A history of chronic infection; a recent (within 6 months) serious or life-threatening infection, including herpes zoster; or any current sign or symptom that may indicate an infection (e.g. fever, cough)
- Use of antibiotic (for any indication) within 2 weeks prior to screening or during the run-in period prior to Visit 3
- A history of lymphoproliferative disorder, including lymphoma or sign and symptoms suggestive of lymphoproliferative disease at any time
- Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infection)
- Patients with known concurrent viral hepatitis or known positivity to HBc-Ab, HBs-AB, HBs-Ag, HBV DNA polymerase, HCV RNA, or anti HCV antibodies
- Receipt of any vaccination (live or attenuated) within 8 weeks prior to Visit 0, with the exception of influenza and pneumococcal vaccines, which are allowed
- Concurrent malignancy or a history of malignancy (other than basal cell carcinoma successfully treated more than 5 years prior to screening)
- Current or recent history of severe, progressive and of uncontrolled renal hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease
- Known human immunodeficiency virus (HIV) infection
- New York heart Association class III-IV congestive heart failure requiring medical treatment
- A history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
- A history of drug or alcohol abuse in the prior year
- Receipt of any experimental therapy within or outside of a clinical treat in the 3 months prior to visit 1
- Any other condition which in the investigator's judgment would make the patient unsuitable for inclusion in the study.
- Biological therapy other than the study drug will not be permitted during the study.
- Patients receiving antibiotics for Crohn’s disease will not be enrolled in the study. Patients requiring such antibiotics during the study will be withdrawn. However, antibiotics for conditions other than Crohn’s disease are permitted during the study. (Patients receiving antibiotics for conditions other than Crohn’s disease must have been off of antibiotic treatment for 2 weeks prior to enrollment).
How long will the Study run?The study enrollment period will be about a year. Participants will be in the study for approximately 38 weeks. What is/are the Locations of this Clinical Trial? University of Utah, Division of Gastroenterology Who can I Contact for Additional Information on this Trial?
Study Coordinator telephone number: (801) 587-9854
TREATMENT OF CHRONIC HEPATITIS C: PEG-INTRON AND RIBAVIRIN WITH OR WITHOUT ADJUVANT THERAPY (KATT)
Principal Investigator: William R. Hutson, M.D.
IRB Approval Number: 18127
Study Status
Study Description: Chronic Hepatitis C is a long-term condition caused by infection of the body with the hepatitis C virus. This infection may result in inflammation or scarring of the liver tissue. Recent advances in the treatment of hepatitis C, using PEG-Intron and Ribavirin combination therapy, have brought overall response rates to over 50% for the first time in the history of this disease. Data reviewed from previous studies suggests that patients who are able to complete treatment with PEG-Intron and Ribavirin and maintain maximum effective doses of these drugs have a 3-times greater chance of getting rid of the virus than those patients who cannot use either drug for at least 80% of the treatment course. Side effects of PEG-Intron and Ribavirin can sometimes cause changes in the blood. This study will investigate whether taking additional drugs will reduce the side effects of PEG-Intron and Ribavirin, and allow patients to better tolerate treatment for Hepatitis C. Key search words (disease/condition specific):Hepatitis C, Peg-Intron, Ribavirin, KATT Who is Eligible to participate in the Study?
Inclusion Criteria:
1. Age between 18 and 70 years.2. Serum positive for HCV-RNA by PCR or a quantitative technique. A historic positive HCV-RNA is useful for screening purpose, but a positive HCV-RNA at entry is required for participation in the study.
3. Hepatitis C genotype 1, 4, 5, or 6.
4. A liver biopsy within 36 months of entry into the study confirming chronic hepatitis C and excluding other causes of chronic liver disease.
5. Compensated liver disease with the following minimum hematologic and biochemical criteria: Hemoglobin ³13 g/dL in males and ³12 g/dL in females; WBC ³ 3,000/mm3, absolute neutrophil count ³ 1,500/mm3; platelet count ³ 75,000/mm3; INR £ 1.7; direct and indirect bilirubin fractions within the upper limit of normal (ULN) for the local laboratory and albumin within 20% of lower limit of normal (LLN) for the local laboratory. Note: If a patient enters the study with less than 80,000 platelets per cubic mm, then they will be started at a reduced dose of Peg-Intron (see Table 1).
6. Serum creatinine £ 1.4 mg/dL. If serum creatinine is greater than 1.4 mg/dL then the creatinine clearance has to be ³ 60 cc/minute.
7. Serum glucose and TSH should be within normal limits or if the patient has diabetes or hypothyroidism these values should be adequately controlled (Hb A1C <8.6%, and normal TSH).
8. If the patient has cirrhosis of the liver, then an alfa-fetoprotein (less than 100 ng/mL) and a RUQ US examination obtained within one year of entry should show no evidence of hepatocellular carcinoma.
9. Serum vitamin B12, folate, iron, transferrin saturation and ferritin levels within normal limits (WNL).
10. Negative pregnancy test for women of childbearing potential
11. Reconfirmation and documentation that sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods [Norplant], medroxyprogesterone acetate [Depo-Provera], surgical sterilization, barrier method [diaphragm + spermicide], or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. A pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast-feeding.
12. Documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy.
13. The subject must be willing to give written informed consent and be able to adhere to dose and visit schedules
Body weight less than 126 kilograms
Exclusion Criteria
1. Other chronic liver diseases such as (but not limited to) coinfection with hepatitis B (positive HBsAg; this must be ruled out within 6 months of study enrollment), and autoimmune liver disease (positive ANA ³ 1:160 and compatible liver histology).
2. Patients with hereditary hemochromatosis will be allowed to participate once they have been adequately iron depleted as is standard of therapy (normal ferritin and transferrin saturation). Patients with alpha-1 antitrypsin deficiency heterozygote phenotypes are allowed to participate.
3. Hepatitis C with genotype 2 or 3 disease.
4. HIV coinfection (must be ruled out within 6 months of study enrollment).
5. Decompensated liver disease as evidenced by ascites or encephalopathy or abnormal serum albumin, bilirubin or prothrombin time as specified in Inclusion Criteria totaling more than 6 points in the Child-Turcotte-Pugh classification.
6. Current use of immunosuppressive drugs for any cause including organ transplantation.
7. Severe psychiatric disorders including bipolar disorder and major depression with or without suicidal ideation or attempt and psychosis unless cleared for participation by a psychiatrist. Severe depression history includes the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or a significant disruption of daily functions. The investigator will formulate a management plan for the patient that will become part of the official medical record. The investigator will review the subjects’ mental status at every visit.
8. Significant cardiovascular dysfunction in the previous 12 months (such as recent coronary surgery, angina, congestive heart failure, uncontrolled angina, hypertension, arrhythmia, or ECG changes consistent with ischemia or strain). Patients on medication for such are eligible if no episodes have occurred in the last 12 months.
9. Hemoglobinopathies or ongoing hemolytic anemias.
10. Patients with clinically significant retinal abnormalities.
11. Poorly controlled diabetes mellitus.
12. Chronic pulmonary disease patients must be cleared for participation by a pulmonologist.
13. CNS trauma or active seizure disorder requiring medication.
14. Immunologically mediated disease (e.g., idiopathic thrombocytopenic purpura, lupus erythematous, autoimmune hemolytic anemia, scleroderma, severe psoriasis, and rheumatoid arthritis).
15. Allergies to interferons, ribavirin, filgrastim, darbepoetin alfa, or Escherichia Coli derived products or any of the product constituents.16. Substance abuse. If the patient has a history of substance abuse, to be considered for inclusion into the protocol, the patient must have abstained from using the abused substance for at least 6 months. Patients receiving methadone within the past 6 months are also excluded unless a program of testing for continued substance abuse is in place or initiated prior to inclusion into the protocol.
17. Alcohol intake ³ 30 gm/day.
18. Women who are pregnant, attempting to conceive or breast-feeding.
19. Received more than 2 units of RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization.
20. Receiving or has recently received chemotherapy and/or radiation therapy for treatment of a malignancy, or clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
21. Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 105 mm Hg).
22. Received androgens within the last 3 months.
23. Active, clinically significant bleeding: requiring hospitalization or blood transfusions.
24. Active infection other than HCV being treated with antibiotics in the previous 14 days.
25. Any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment, or which could interfere with the patient participating and completing the protocol. How long will the Study run?The study will be enrolling until approximately 6/2007. What is/are the Locations of this Clinical Trial? University of Utah, Division of Gastroenterology Who can I Contact for Additional Information on this Trial?
A Prospective Randomized Trial Comparing Direct Intraneronal Injection of the Celiac Ganglia versus Injection into the Perineronal Space for the Treatment of Chronic Abdominal Pain in Patients with Pancreatic Cancer or Chronic Pancreatitis.
Principal Investigator: Douglas Adler, M.D.
IRB Approval Number:
Study Description: Patients presenting with chronic pancreatitis and pancreatic cancer often have chronic abdominal pain that can be very hard to control. Traditional pharmacological therapy using opioids often relieve symptoms; however, patients often experience a multitude of side effects such as dry mouth, constipation, nausea, vomiting, drowsiness, delirium, and impaired immune function.
In addition, prolonged use of these medications is also associated to narcotic dependence and a decrease in quality of life.
Celiac plexus block (CPB) is an alternative therapy that temporarily blocks the pain through an injection of bupivacaine into the perineronal space in an attempt to inhibit the celiac plexus. Endoscopic ultrasound is used to locate the celiac artery and bupuvacaine is injected into the perineronal space located on either side of the celiac artery. Recently, two separate studies each described the presence of neural ganglia by endoscopic ultrasound. In both studies the ganglia were seen anterior to the aorta, and between the celiac artery and left adrenal gland and diagnosis was confirmed through EUS guided fine needle aspiration (FNA).
To date, there is no prospective study comparing direct injection of the ganglia versus injection into the perineronal space. We would like to determine whether direct injection into the celiac ganglia is more effective in relieving chronic abdominal pain than injection into the perineronal space.
Key search words (disease/condition specific):Celiac plexus block (CPN), celiac plexus neurolysis, chronic opioid use Who is Eligible to participate in the Study?
- Age Range: >18
- Inclusion Criteria
- 18 years of age or older
- Diagnosis of pancreatic cancer or chronic pancreatitis
- Ability to provide informed consent
- Active alcohol or substance use
- Women who are pregnant or lactating
- Active use of anticoagulative therapy
How long will the Study run?The study enrollment period will be about a year. Participants will be in the study for approximately 4 months. What is/are the Locations of this Clinical Trial? University of Utah, Division of Gastroenterology Who can I Contact for Additional Information on this Trial?
IRB Approval Number: 15444
Principal Investigator: Kathryn A. Peterson, M.D., MSci
Study Status
Study Description: Currently, many Americans suffer from asthma. The exact mechanism by which airway inflammation leads to asthma symptoms has yet to be clearly explained. In previous studies, persons with asthma appear to have different types of inflammation in their lungs. The reasons for this difference remain a mystery. Allergy is known to play a role in the constriction of the muscle in the airways (bronchospasm). Other mechanisms have not been discovered. The purpose of this study is to determine how heartburn may lead to different types of inflammation in one’s airways. Additionally, we hope to determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by biopsy. The results of this study will be important in directing future research into the relationship between heartburn and asthma and may provide a clue whether certain subtypes of asthma may be caused primarily by GER. Key search words (disease/condition specific):Asthma, gastroesophageal reflux, pulmonary inflammation Who is Eligible to participate in the Study?
- Age Range: 18-65
- Inclusion Criteria
1. Moderate asthmatic
2. Complaints of gastroesophageal reflux
1. Severe asthmatics who have been hospitalized within the last 6 months or who have required oral steroid use within the last 4 weeks
2. Severe coronary artery disease
3. Cigarette/cigar smoking within the last 6 months
4. Documented allergies affecting the respiratory system
5. Subjects with contraindications to pH/impedance probe
a. Hemophilia
b. Septal deviation
6. Subjects with contraindications to bronchoscopy as outlined by the American Thoracic Society Guidelines
7. Anticoagulation
8. Pregnancy
9. Incarcerated patients
10. Current oral steroid use (may suppress levels of inflammation)
11. Upper respiratory infection within the last 2 weeks
12. Ongoing acid suppression with a proton pump inhibitor, however, patients may be included if they have discontinued their proton pump inhibitor within the last 1 month with stable asthma symptoms as defined by stable utilization of inhaled steroids
How long will the Study run?The study enrollment period will be about a year. Participants will be in the study for approximately 4 months. What is/are the Locations of this Clinical Trial? University of Utah, Division of Gastroenterology Who can I Contact for Additional Information on this Trial?
Study Coordinator telephone number: (801) 587-9854
A Phase IIIb Multi-Center, Double-Blind, Placebo-Controlled, Randomized Trial to Examine the Corticosteroid-Sparing Effect of Certolizumab Pegol in Patients with Moderate to Severe Crohn’s Disease (COSPAR I)
Principal Investigator: Christopher Tietze, M.D., Ph.D.
IRB Approval Number: 20541 Study Status
Study Description: Certolizumab pegol is an investigational into-TNF a agent. It is an engineered, humanized monoclonal antibody Fab' fragment that is manufactured in E coli, subsequently purified and conjugated to polyethylene glycol. It is intended for subcutaneous administration. The engineered Fab' fragment retains the biologic potency of the original antibody. It binds to human TNF a with high affinity, thus neutralizing its biological activity. Certolizumab pegol does not lyse cells that express high levels of membrane-bound TNF a. The site-specific polyethylene glycolation increases the half-life of the antibody fragment to approximately 2 weeks in plasma, thereby reducing the frequency of required dosing.
The purpose of the present study is to assess the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have received initial acute therapy with prednisone to prednisolone for induction of remission. During double-blind study treatment, patient will be tapered off the corticosteroids according to a standard schedule, which will allow complete steroid withdrawal in 8-10 weeks. Patients who are successfully tapered and discontinued from the corticosteroid will continue to receive double-blind treatment through Week 36 and the maintenance of remission will be followed through Week 38 of the study.
Key search words (disease/condition specific):Crohn’s Disease, certolizumab pegol, TNF aWho is Eligible to participate in the Study?
Inclusion Criteria
- Patient is able to understand the information provided to them and who have given written informed consent to the study
- Patient is able to understand and complete self-administered questionnaires
- Men and women, age 18 years or older
- A diagnosis of moderate to severe Crohn's disease (CDAI of > 200- <450) during the run-in period
- The patient is a candidate for treatment with prednisone or prednisolone therapy, but is not on maintenance corticosteroid therapy
- If the patient is on an immunosuppressant (azathioprine, 6-mercaptopurine, and methotrexate are allowed immunosuppressant), the dose has to have been stable for at least 8 weeks prior to screening and is expected to remain stable during the study
- If the patient is on a 5-ASA analogue for Crohn's disease, the dose has to have been stable for at least 4 weeks prior to screening and is expected to remain stable during the study.
- If female, the patient is either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or perineal hormonal contraceptive; intrauterine device; barrier and spermicidal—abstinence is not an acceptable method). Patients must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab
Crohn’s Disease Related
- Prior treatment with anti-TNF a therapy, including certolizumab pegol
- Active or draining fistula present at screening
- On maintenance corticosteroid therapy
- Symptomatic obstructive intestinal strictures
- Functional colostomy or ileostomy (patients who have a temporary stoma in the past, which as been reversed, are eligible to enter the study)
- Bowel resection within 3 months of starting the study medication
- Current total parenteral nutrition
- Short bowel syndrome
- Positive stool laboratory results for pathogens
- Antibiotic treatment for Crohn's disease within 2 weeks prior to screening.
Medical History related
- Ulcerative colitis
- Irritable bowel syndrome
- Other autoimmune disease (e.g. rheumatoid arthritis, lupus erythematosus)
- Lactating and/or pregnant female patients
- If female, a positive serum pregnancy test at screening or a positive urine pregnancy test prior to dosing
- A history of tuberculosis (TB) or positive PPD skin test (defined as positive induration of >5 mm). patients with a positive PPD skin test who have received BCG vaccination and have a negative chest X-ray for TB may be enrolled the discretion of the investigator
- A history of chronic infection; a recent (within 6 months) serious or life-threatening infection, including herpes zoster; or any current sign or symptom that may indicate an infection (e.g. fever, cough)
- Use of antibiotic (for any indication) within 2 weeks prior to screening or during the run-in period prior to Visit 3
- A history of lymphoproliferative disorder, including lymphoma or sign and symptoms suggestive of lymphoproliferative disease at any time
- Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infection)
- Patients with known concurrent viral hepatitis or known positivity to HBc-Ab, HBs-AB, HBs-Ag, HBV DNA polymerase, HCV RNA, or anti HCV antibodies
- Receipt of any vaccination (live or attenuated) within 8 weeks prior to Visit 0, with the exception of influenza and pneumococcal vaccines, which are allowed
- Concurrent malignancy or a history of malignancy (other than basal cell carcinoma successfully treated more than 5 years prior to screening)
- Current or recent history of severe, progressive and of uncontrolled renal hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease
- Known human immunodeficiency virus (HIV) infection
- New York heart Association class III-IV congestive heart failure requiring medical treatment
- A history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
- A history of drug or alcohol abuse in the prior year
- Receipt of any experimental therapy within or outside of a clinical treat in the 3 months prior to visit 1
- Any other condition which in the investigator's judgment would make the patient unsuitable for inclusion in the study.
- Biological therapy other than the study drug will not be permitted during the study.
- Patients receiving antibiotics for Crohn’s disease will not be enrolled in the study. Patients requiring such antibiotics during the study will be withdrawn. However, antibiotics for conditions other than Crohn’s disease are permitted during the study. (Patients receiving antibiotics for conditions other than Crohn’s disease must have been off of antibiotic treatment for 2 weeks prior to enrollment).
- How long will the Study run?
The study enrollment period will be about a year. Participants will be in the study for approximately 38 weeks. What is/are the Locations of this Clinical Trial? University of Utah, Division of Gastroenterology Who can I Contact for Additional Information on this Trial?
TREATMENT OF CHRONIC HEPATITIS C: PEG-INTRON AND RIBAVIRIN WITH OR WITHOUT ADJUVANT THERAPY (KATT)
Principal Investigator: William R. Hutson, M.D.
IRB Approval Number: 18127
Study Status
Study Description: Chronic Hepatitis C is a long-term condition caused by infection of the body with the hepatitis C virus. This infection may result in inflammation or scarring of the liver tissue. Recent advances in the treatment of hepatitis C, using PEG-Intron and Ribavirin combination therapy, have brought overall response rates to over 50% for the first time in the history of this disease. Data reviewed from previous studies suggests that patients who are able to complete treatment with PEG-Intron and Ribavirin and maintain maximum effective doses of these drugs have a 3-times greater chance of getting rid of the virus than those patients who cannot use either drug for at least 80% of the treatment course. Side effects of PEG-Intron and Ribavirin can sometimes cause changes in the blood. This study will investigate whether taking additional drugs will reduce the side effects of PEG-Intron and Ribavirin, and allow patients to better tolerate treatment for Hepatitis C. Key search words (disease/condition specific):Hepatitis C, Peg-Intron, Ribavirin, KATT Who is Eligible to participate in the Study?
Inclusion Criteria:
1. Age between 18 and 70 years.2. Serum positive for HCV-RNA by PCR or a quantitative technique. A historic positive HCV-RNA is useful for screening purpose, but a positive HCV-RNA at entry is required for participation in the study.
3. Hepatitis C genotype 1, 4, 5, or 6.
4. A liver biopsy within 36 months of entry into the study confirming chronic hepatitis C and excluding other causes of chronic liver disease.
5. Compensated liver disease with the following minimum hematologic and biochemical criteria: Hemoglobin ³13 g/dL in males and ³12 g/dL in females; WBC ³ 3,000/mm3, absolute neutrophil count ³ 1,500/mm3; platelet count ³ 75,000/mm3; INR £ 1.7; direct and indirect bilirubin fractions within the upper limit of normal (ULN) for the local laboratory and albumin within 20% of lower limit of normal (LLN) for the local laboratory. Note: If a patient enters the study with less than 80,000 platelets per cubic mm, then they will be started at a reduced dose of Peg-Intron (see Table 1).
6. Serum creatinine £ 1.4 mg/dL. If serum creatinine is greater than 1.4 mg/dL then the creatinine clearance has to be ³ 60 cc/minute.
7. Serum glucose and TSH should be within normal limits or if the patient has diabetes or hypothyroidism these values should be adequately controlled (Hb A1C <8.6%, and normal TSH).
8. If the patient has cirrhosis of the liver, then an alfa-fetoprotein (less than 100 ng/mL) and a RUQ US examination obtained within one year of entry should show no evidence of hepatocellular carcinoma.
9. Serum vitamin B12, folate, iron, transferrin saturation and ferritin levels within normal limits (WNL).
10. Negative pregnancy test for women of childbearing potential
11. Reconfirmation and documentation that sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods [Norplant], medroxyprogesterone acetate [Depo-Provera], surgical sterilization, barrier method [diaphragm + spermicide], or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. A pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast-feeding.
12. Documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy.
13. The subject must be willing to give written informed consent and be able to adhere to dose and visit schedules
Body weight less than 126 kilograms
Exclusion Criteria
1. Other chronic liver diseases such as (but not limited to) coinfection with hepatitis B (positive HBsAg; this must be ruled out within 6 months of study enrollment), and autoimmune liver disease (positive ANA ³ 1:160 and compatible liver histology).
2. Patients with hereditary hemochromatosis will be allowed to participate once they have been adequately iron depleted as is standard of therapy (normal ferritin and transferrin saturation). Patients with alpha-1 antitrypsin deficiency heterozygote phenotypes are allowed to participate.
3. Hepatitis C with genotype 2 or 3 disease.
4. HIV coinfection (must be ruled out within 6 months of study enrollment).
5. Decompensated liver disease as evidenced by ascites or encephalopathy or abnormal serum albumin, bilirubin or prothrombin time as specified in Inclusion Criteria totaling more than 6 points in the Child-Turcotte-Pugh classification.
6. Current use of immunosuppressive drugs for any cause including organ transplantation.
7. Severe psychiatric disorders including bipolar disorder and major depression with or without suicidal ideation or attempt and psychosis unless cleared for participation by a psychiatrist. Severe depression history includes the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or a significant disruption of daily functions. The investigator will formulate a management plan for the patient that will become part of the official medical record. The investigator will review the subjects’ mental status at every visit.
8. Significant cardiovascular dysfunction in the previous 12 months (such as recent coronary surgery, angina, congestive heart failure, uncontrolled angina, hypertension, arrhythmia, or ECG changes consistent with ischemia or strain). Patients on medication for such are eligible if no episodes have occurred in the last 12 months.
9. Hemoglobinopathies or ongoing hemolytic anemias.
10. Patients with clinically significant retinal abnormalities.
11. Poorly controlled diabetes mellitus.
12. Chronic pulmonary disease patients must be cleared for participation by a pulmonologist.
13. CNS trauma or active seizure disorder requiring medication.
14. Immunologically mediated disease (e.g., idiopathic thrombocytopenic purpura, lupus erythematous, autoimmune hemolytic anemia, scleroderma, severe psoriasis, and rheumatoid arthritis).
15. Allergies to interferons, ribavirin, filgrastim, darbepoetin alfa, or Escherichia Coli derived products or any of the product constituents.16. Substance abuse. If the patient has a history of substance abuse, to be considered for inclusion into the protocol, the patient must have abstained from using the abused substance for at least 6 months. Patients receiving methadone within the past 6 months are also excluded unless a program of testing for continued substance abuse is in place or initiated prior to inclusion into the protocol.
17. Alcohol intake ³ 30 gm/day.
18. Women who are pregnant, attempting to conceive or breast-feeding.
19. Received more than 2 units of RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization.
20. Receiving or has recently received chemotherapy and/or radiation therapy for treatment of a malignancy, or clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
21. Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 105 mm Hg).
22. Received androgens within the last 3 months.
23. Active, clinically significant bleeding: requiring hospitalization or blood transfusions.
24. Active infection other than HCV being treated with antibiotics in the previous 14 days.
25. Any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment, or which could interfere with the patient participating and completing the protocol. How long will the Study run?The study will be enrolling until approximately 6/2007. What is/are the Locations of this Clinical Trial? University of Utah, Division of Gastroenterology Who can I Contact for Additional Information on this Trial?
Study Coordinator telephone number: (801) 587-9854
A Prospective Randomized Trial Comparing Direct Intraneronal Injection of the Celiac Ganglia versus Injection into the Perineronal Space for the Treatment of Chronic Abdominal Pain in Patients with Pancreatic Cancer or Chronic Pancreatitis.
Principal Investigator: Douglas Adler, M.D.
IRB Approval Number:
Study Status
Study Description: Patients presenting with chronic pancreatitis and pancreatic cancer often have chronic abdominal pain that can be very hard to control. Traditional pharmacological therapy using opioids often relieve symptoms; however, patients often experience a multitude of side effects such as dry mouth, constipation, nausea, vomiting, drowsiness, delirium, and impaired immune function.
In addition, prolonged use of these medications is also associated to narcotic dependence and a decrease in quality of life.
Celiac plexus block (CPB) is an alternative therapy that temporarily blocks the pain through an injection of bupivacaine into the perineronal space in an attempt to inhibit the celiac plexus. Endoscopic ultrasound is used to locate the celiac artery and bupuvacaine is injected into the perineronal space located on either side of the celiac artery. Recently, two separate studies each described the presence of neural ganglia by endoscopic ultrasound. In both studies the ganglia were seen anterior to the aorta, and between the celiac artery and left adrenal gland and diagnosis was confirmed through EUS guided fine needle aspiration (FNA). To date, there is no prospective study comparing direct injection of the ganglia versus injection into the perineronal space. We would like to determine whether direct injection into the celiac ganglia is more effective in relieving chronic abdominal pain than injection into the perineronal space. Key search words (disease/condition specific):Celiac plexus block (CPN), celiac plexus neurolysis, chronic opioid useWho is Eligible to participate in the Study?
- Age Range: >18
- Inclusion Criteria
- 18 years of age or older
- Diagnosis of pancreatic cancer or chronic pancreatitis
- Ability to provide informed consent
- Active alcohol or substance use
- Women who are pregnant or lactating
- Active use of anticoagulative therapy
How long will the Study run?The study enrollment period will be about a year. Participants will be in the study for approximately 4 months. What is/are the Locations of this Clinical Trial? University of Utah, Division of Gastroenterology Who can I Contact for Additional Information on this Trial?
Elucidation of Acid-Induced Pulmonary Inflammation
Principal Investigator: Kathryn Peterson
IRB Approval Number: 00015444 Study Status
Study Description: There have been mutliple studies looking at the response of asthma to acid suppression. However, the endpoints are difficult to define and the response of asthma to acid suppression is still argued, especially the degree of pulmonary improvement. It does appear that there is a strong correlation between acid reflux and pulmonary problems. How acid reflux contributes to the pathophysiology of such diseases as asthma has neever been studied. We propose to define which mediators of inflammation are mediated through esophageal acid. Our objectives are to determine which inflammatory mediators in asthma are reduced when asthmatics with GER (gastroesophageal reflux) are treated with acid supression. We hope to elucidate whether levels of specific mediators implicated in the pathogenesis of fibrosis and bronchoconstriction are directly related to acid reflux.
We hope to accomplish this by measuring inflammatory mediators in the airways of asthmatics (by bronchoscopy with biopsies and lavage) and determining whether they diminish after after suppression (by repeat bronchoscopy with biopsies). Key search words (disease/condition specific):GERDAsthma Who is Eligible to participate in the Study?
- Age Range: 18-65
- Inclusion Criteria: Patients with moderate asthma who have been on stable inhaler regimen for approximately one month prior to enrollment with symptoms of gastroesophageal reflux.
- Exclusion Criteria: Any recent hospitalization for asthma or other pulmonary condition. Any unstable cardiovascular disease or other underlying pulmonary condition. Any sudden worsening of asthma requiring greater than 3 months of oral steroids.
How long will the Study run?26 months What is/are the Locations of this Clinical Trial?University of Utah's Covered EntityVeterans Affairs SLC Health Care System (VAMC) Who can I Contact for Additional Information on this Trial?
- Study Coordinator Name: Fatima Gangotena
- Study Coordinator Email Address: Fatima.Gangotena@hsc.utah.edu
- Study Coordinator telephone number: 801-587-9092
A phase II study to assess the safety and methods for determining the efficacy of RG1068 (synthetic human secretin) – enhanced magnetic resonance cholangiopancreatography (MRCP) in the evaluation of patients with a history of acute or acute recurrent pancreatitis
Principal Investigator: Jason C. Wills, M.D.
Co-Investigators: James A. Disario, M.D., Akram Shaaban, M.D., Douglas Adler, M.D.
IRB# 18401.
Study Status: Open to enrollment until late 2007 at the University of Utah HSC/Huntsman Cancer Hospital.
The purpose of this study is to 1) determine the variability of central MRCP and ERCP readers in detecting pancreatic duct abnormalities 2) assess the sensitivity and specificy of RG1068-enhanced MRCP relative to unenhanced MRCP for detecting pancreatic duct abnormalities using an ERCP-based truth standard.Key words: secretin, ERCP, MRCP, pancreatitisBiological and synthetic porcine secretions have been used for over six decades in the assessment of pancreatic exocrine function. More recently, secretin has gained wide acceptance in Europe for use with MRCP to improve visualization of pancreaticobiliary structures and diagnostic sensitivity relative to unenhanced MRCP and to obviate the need for more invasive procedures such as ERCP. MRCP uses stationary water in biliary and pancreatic structures as an intrinsic contrast medium, thus facilitating examination of pancreatic and biliary ducts and surrounding tissue. Secretin, which promotes the secretion of pancreatic fluid into the pancreatic ducts, can thereby enhance the MR imaging signal, improving delineation of both normal and abnormal structures. MRCP will be performed and images will be obtained prior to the administration of RG1068. The subject will receive an IV infusion of RG1068 over a period of one minute. MRI sequences of the pancreas will be acquired at 1 minute intervals for ten minutes following RG1068 administration. Blood samples will be collected 24-48 post RG1068 infusion and ERCP will be performed 1 – 30 days following MRCP.
Who is eligible? Subjects 18 and over with a history of acute recurrent pancreatitis or a single episode of acute pancreatitis requiring ERCP. Subjects with a pancreatitic stent, history of pancreatitic duct drainage procedure, history of pancreatitic resection, or those with active acute pancreatitis requiring pancreatic rest are not eligible.
Contact for more information:
Kristen Hilden, M.S.801-581-6393kristen.hilden@hsc.utah.edu
A phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of three different doses (275, 550 and 1100 mg) of rifaximin administered BID for either two or four weeks in the treatment of patients with diarrhea-associated irritable bowel syndrome.
Principal Investigator: John C. Fang, M.D.
Co-investigator: Ashok K. Tuteja, M.D., M.P.H.
IRB#16993.
Study Status: Open to enrollment until mid 2007 at the University of Utah HSCKey words: Irritable bowel syndrome, diarrhea-predominant irritable bowel syndromeThe objective of this trial is to evaluate the efficacy of a 14-day course of oral rifaximin at 550 mg twice daily versus placebo in providing adequate relief from diarrhea-associated irritable bowel syndrome (DIBS) symptoms.Currently, there is only one generally acceptable drug approved for DIBS (Lotronex). The use of Lotronex has been associated with some serious gastrointestinal adverse events including death, ischemic colitis and serious complications of constipation. Rifaximin is a minimally absorbed antibiotic currently used for the treatment of Traveler’s diarrhea. Rifaximin may provide meaningful relief of the symptoms of IBS for those patients that are not adequately relieved by diet, antispasmodics or are not ideal candidates for Lotronex.Subjects may be required to undergo a colonoscopy or flexible sigmoidoscopy prior to screening for this study if they have not done so in the past two years. Subjects may also be asked to participate in lactulose breath testing. After meeting qualification criteria, subjects will receive treatment for 14-28 days and may be followed for up to 17 weeks depending on response to treatment. Subjects will be required to undergo routine office visits, laboratory testing, stool sample testing, answer questionnaires and complete daily phone diary calls.Who is eligible?Males and females 18 years of age or olderSubjects with DIBS symptoms; subjects who alternate between diarrhea and constipation are acceptable as long as they do not present with constipation.Subjects with inadequate control of their DIBS symptoms.Subjects currently Lotronex are not eligible.Participants will receive compensation. All procedures associated with this study will be paid for by the study.Contact for more information:Kristen Hilden, M.S.
801-581-3693
kristen.hilden@hsc.utah.edu
A Study of OncoGel® Treatment as an Adjunctive Therapy to XRT
in Patients with Inoperable Esophageal Cancer
Principal Investigator: Jason C. Wills, M.D.
Co-investigator: Keith G. Tolman, M.D.
Dennis C. Shrieve, M.D., Ph.D.IRB#12266Study Status: Open to enrollment until mid-2007 at the University of Utah HSC/Huntsman Cancer HospitalKey words: Esophageal cancer, dysphagiaThe purpose of this study is to determine whether OncoGel® may be safely given along with radiation therapy. The study will also test whether OncoGel helps treat dysphagia (difficulty swallowing) in patients with esophageal cancer.OncoGel® is a new investigational and anticancer drug, approved by the FDA. Patients participating in this study have esophageal cancer and have difficulty swallowing (called dysphagia). External beam radiation therapy has been recommended as a treatment to relieve the difficulty swallowing. OncoGel® is an experimental drug delivery system that allows the slow continuous release of paclitaxel over a long period of time. The purpose of this study is to determine whether OncoGel® may be safely given along with radiation therapy. The study will also test whether OncoGel® helps treat the difficulty in swallowing.
The purpose of this study is to find answers to the following questions.
• What is the largest, single dose of OncoGel (participants will only receive one dose) that can be placed safely directly into a tumor within the esophagus when given along with radiation?
• What are the side effects of OncoGel when placed directly into an esophageal tumor?
• How much of the paclitaxel in OncoGel gets into the bloodstream following placement into an esophageal tumor?
• Is OncoGel useful in relieving difficulty swallowing when used with external beam radiation therapy?Overall participation in this study is 7 weeks from Dosing Day 1.Who is eligible?Patients aged 18 years or older that have been diagnosed with inoperable esophageal cancer. The size of the esophageal tumor must be known, an instrument called an endoscope will be used to locate and measure the size of the tumor. Contact for more information:
Kristen Hilden, M.S.
801-581-3693
kristen.hilden@hsc.utah.edu
A Pilot study of the treatment of eosinophilic esophagitis with omalizumab
Principal Investigator: John C. Fang, M.D.
Co-investigators: Kathryn Peterson, M.D. (Gastroenterlogy); Gerald Gleich, M.D. (Dermatology); Molly O’Gormon, M.D (Gastroenterology, Primary Children’s Medical Center).; Daniel Jackson, M.D. (Gastroenterology, Primary Children’s Medical Center); Lyska Emerson, M.D. (Pathology); Amy Lowichik, M.D., Ph.D. (Pathology, Primary Children’s Medical Center).
IRB#13623.
Study Status: Open to enrollment until late 2007 at the University of Utah HSC/Huntsman General Clinical Research Center, Primary Children’s Hospital, and the VA Salt LakeKey words: Eosinophilic esophagitis, eosinophils, dysphagia, GERD, allergic asthmaThis research study is comparing omalizumab (Xolair) or placebo for eosinophic esophagitis (EE) in adults and adolescents (12-17). Participants in this study must have recurrent symptoms after at least an 8 week course of fluticasone (Flovent).Patients who participate in this study will have a condition called eosinophilic esophagitis (EE). This is a condition where the lining of the esophagus (food pipe) becomes filled with a specific type of cell called and eosinophil. This cell type is associated with both allergy and gastroesophageal reflux (GER). To date, it is unclear whether the condition is due to allergy or to GER.Omalizumab is a recently developed anti-IgE antibody that has been used to decrease asthma symptoms in patients with allergic asthma.Participants in this study will undergo an initial endoscopy with biopsies to determine the presence of eosinophils in the esophagus. If the subject qualifies for the study, the subject will be randomized to omalizumab or placebo therapy for 16 weeks. This study requires subcutaneous injections bi-weekly or monthly for 16 weeks followed by a second endoscopy. Randomized means that the therapy will not be pre-determined, and participants will have an equal chance to receive either one of the therapies. Also, participants will be asked to fill out questionnaires during the study. These questionnaires will be used to determine whether your symptoms have inproved.Who is eligible?Patients aged 12-60 with eosinophilic esophagitis (EE).
Recurrent symptoms of EE (difficulty swallowing) after at least an 8 week course of fluticasone.Participants will receive compensation. All procedures associated with this study will be paid for by the study.
Contact for more information:
Kristen Hilden, M.S.
801-581-3693
kristen.hilden@hsc.utah.edu
Comparison of Solid-State Catheters with Air Filled Multi- Balloon Catheters
Principal Investigator: John C. Fang, M.D.
Co-investigators: Kathryn A. Peterson, M.D., Ashok K. Tuteja, M.D. The purpose of this study is to determine if newly developed manometry catheters are as accurate as presently used manometry catheters. IRB# 12127.
Open to enrollment until early 2007 at the University of Utah HSC Key words: Manometry catheters, schleroderma, achalasia, nutcracker esophagus, diffuse esophageal spasm, hypertensive LES, incontinence.
Manometry catheters are small flexible tubes (less than the size of a pencil) inserted in your esophagus (food pipe) or rectum to measure the pressures that are generated in those areas. They are used for diagnostic testing when patients have symptoms of either esophageal or anorectal dysfunction. Presently used manometry catheters use solid-state technology to measure these pressures. The new catheters to be tested use air filled balloons to measure pressures. The Food and Drug Administration (FDA) approve all catheters used in this study. Subjects with abnormal esophageal motility (schleroderma, achalasia, nutcracker esophagus, diffuse esophageal spasm, hypertensive LES) or subjects with incontinence who have already undergone esophageal or anorectal manometry (whichever is appropriate to the disease/condition) will undergo repeat manometry using air-filled balloon catheters. Who is eligible? Subjects who have been diagnosed with esophageal motility disorders (schleroderma, achalasia, nutcracker esophagus, diffuse esophageal spasm, hypertensive LES) or anorectal motility disorder of incontinence who have previously undergone manometry. Subjects will be compensated for the repeat manometry procedure. Subjects with previous esophageal or anorectal surgery, anatomic abnormalities or dysfunction will be ineligible to participate. Contact for more information: Kristen Hilden, M.S.801-581-6393kristen.hilden@hsc.utah.edu
