Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Viramidine
* Drug: Peginterferon alfa-2b


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Viramidine|nan|
|Drug: Peginterferon alfa-2b|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viramidine, Peginterferon alfa-2b, Valeant, Hepatitis C, Rapid virologic response, HCV RNA