Status:
COMPLETED
High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the effectiveness of an experimental treatment regimen for hepatitis C (HCV). Standard treatment consists of combination therapy with ribavirin, taken by mouth twice a day, an...
Detailed Description
Up to 60 patients with chronic hepatitis C genotype 1 infection who were previously treated with standard doses of peginterferon and ribavirin (1000 to 1200 mg daily) but who did not have a virologica...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18 years or above, male or female
- Documented relapse or non-response to a prior adequate course of peginterferon and ribavirin
- Genotype 1 HCV as determined by probe specific hybridization (Inno-Lipa assay).
- Written informed consent.
- EXCLUSION CRITERIA:
- Age greater than 65 years
- If cirrhosis is present, decompensated liver disease, as marked by serum bilirubin greater than 4 mg percent, albumin less than 3.0 gm percent, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
- Serum Alanine transaminase (ALT) or Aspartate transaminase (AST) levels greater than 1000 U/L (greater than 25 times the ULN). Such patients will not be enrolled but may be followed until three determinations are below this level.
- Pregnancy or, in women of child bearing potential or in spouses of pregnant women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device.
- Breastfeeding.
- Significant systemic or major illnesses including congestive heart failure, organ transplantation, serious psychiatric disease or depression, human immunodeficiency virus (HIV) infection, and angina pectoris.
- Previous intolerance of weight based ribavirin dose (1,000-1,200 mg daily) including need for dose reduction, use of erythropoietin or serious adverse event attributable to ribavirin use.
- Renal insufficiency (creatinine clearance less than 60 ml/min) or renal failure
- Pre existing anemia (hematocrit less than 34 percent) or known history of hemolytic anemia.
- Uncontrolled hypertension or diabetes mellitus
- Other antiviral therapy within the last 6 months.
- Immunosuppressive therapy with either corticosteroids (more than 5 mg of prednisone daily) or major immunosuppressive agents (such as azathioprine or 6-mercaptopurine).
- Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, Wilson disease, alcoholic liver disease, hemochromatosis, alpha 1 antitrypsin deficiency).
- Evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.
- Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
- Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
- Clinical gout.
- Active, serious autoimmune disease, such as lupus erythematosis, ulcerative colitis, Crohn s disease or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with peginterferon.
- Uncontrolled thyroid disease
- Evidence if severe retinopathy or clinically relevant ophthalmological disorder (only patients with pre-existing hypertension or diabetes will undergo an ophthalmological assessment).
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00735969
Start Date
August 1 2008
End Date
June 1 2013
Last Update
October 20 2014
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892