Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT00093093
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.
- Detailed Description
Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
- Treatment-naive patients with compensated chronic hepatitis C.
- HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).
- Severe neuropsychiatric disorders
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
- Pregnant or breast-feeding patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period. - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.
- Secondary Outcome Measures
Name Time Method - Efficacy: Undetectable plasma HCV RNA at treatment week 24 - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24 - Safety: Monitoring of adverse events - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related
Trial Locations
- Locations (100)
University of Arizona
🇺🇸Tucson, Arizona, United States
UCSF Fresno- Internal Medicine
🇺🇸Fresno, California, United States
Keck School of Medicine, University of Southern California
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Orange Coast Medical Group
🇺🇸Newport Beach, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Research and Education, Inc.
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
San Mateo Medical Center
🇺🇸San Mateo, California, United States
Scroll for more (90 remaining)University of Arizona🇺🇸Tucson, Arizona, United States