Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT00305383
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.
- Detailed Description
This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
- Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients
- Body weight greater than 61 kg and not more than 87.3 kg
- HCV RNA greater than 2 million copies/mL
- Elevated measured or historical alanine aminotransferase
- Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males
- Calculated creatinine clearance greater than 70 mL/min
- Cirrhosis of the liver
- Alanine aminotransferase greater than 3 times the upper limit of normal
- Severe neuropsychiatric disorders
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
- Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy: The proportion of patients with hepatitis C virus (HCV) RNA undetectable or with at least a 2-log drop from baseline at CT Week 4 in the viramidine pre-load group versus the viramidine standard dosing group. Safety: Evaluation of adverse events (AEs). Safety: Physical exams Safety: Vital signs Safety: Laboratory tests
- Secondary Outcome Measures
Name Time Method Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.
Trial Locations
- Locations (11)
Maryland Digestive Disease Research
🇺🇸Laurel, Maryland, United States
San Mateo Medical Center
🇺🇸San Mateo, California, United States
Liver Center of Long Island
🇺🇸Plainview, New York, United States
Atlantic Gastroenterology Associates
🇺🇸Egg Harbor Township, New Jersey, United States
Thomas Jefferson University -- Gastroenterology and Hepatology
🇺🇸Philadelphia, Pennsylvania, United States
Metropolitan Research -- Georgetown Medical Center
🇺🇸Fairfax, Virginia, United States
University of Miami -- Center for Liver Diseases
🇺🇸Miami, Florida, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Mountain West Gastroenterology -- Research Office
🇺🇸Salt Lake City, Utah, United States
University of Southern California -- Keck School of Medicine
🇺🇸Los Angeles, California, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States