Overview

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Asunaprevir
Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Criteria
Key Inclusion Criteria:

- Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to
control arm (pegIFNα-2a/ribavirin + placebo) during the trial

- Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)

- HCV RNA viral load detectable

Key Exclusion Criteria:

- Discontinuation from a prior BMS HCV clinical trial due to a
pegIFNα-2a/ribavirin-related event

- Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or
BMS-791325

- Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2
antibody at screening

- Evidence of medical condition associated with chronic liver disease other than HCV
infection

- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy