NCT00305383

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Viramidine
DRUG	Peginterferon alfa-2b

Timeline

• Start date: 2005-11-01
• Completion: 2007-05-01
• First posted: 2006-03-21
• Last updated: 2012-06-22

Locations

11 sites across 1 country: United States