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Clinical Trial Summary

The purpose of this study is to provide anti-HCV drugs to +/- 200 subjects treated in prior BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition of these drugs can result in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received placebo will be treated with active drugs in this study.


Clinical Trial Description

- Intervention Model:

- Parallel: for all subjects entering the trial

- Cross-over: for genotype 1b subjects rolling over from AI447-028 who require rescue therapy after initial treatment in this study

- Peginterferon Alfa-2a (pegIFNα-2a)

- Ribavirin (RBV)

- Daclatasvir (DCV)

- Asunaprevir (ASV) ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01428063
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 2
Start date September 2011
Completion date December 2014

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