NCT00230958CompletedPhase 3
Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 900
- Primary Endpoint
- - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
Study Overview
Brief Summary
This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.
Detailed Description
Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2b to treatment-naive patients with chronic hepatitis C (CHC)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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, opthalmologic disorders including severe retinopathy, or immune mediated disease
- •Pregnant or breast-feeding patients
Outcomes
Primary Outcomes
- 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 Outcomes
- - 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
Investigators
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