Hepatitis C, Chronic
Conditions
Keywords
Viramidine, Peginterferon alfa-2b, Valeant, Hepatitis C, Rapid virologic response, HCV RNA
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.
Interventions
DRUGViramidine
DRUGPeginterferon alfa-2b
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24. | — |
Countries
United States
Outcome results
None listed