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

Phase 2TerminatedNCT00305383

Bausch Health Americas, Inc.100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Hepatitis C, Chronic

Interventions

ViramidineDRUG

Peginterferon alfa-2bDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (11)

University of Southern California -- Keck School of Medicine

Los Angeles, California, United States

San Mateo Medical Center

San Mateo, California, United States

Bach and Godofsky

Bradenton, Florida, United States

Outcomes

Primary Outcomes

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 Outcomes

Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.

Data from ClinicalTrials.gov

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