Status:
COMPLETED
Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 whet...
Detailed Description
* Intervention Model: * Parallel: for all patients entering the trial * Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial tre...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT01428063
Start Date
September 1 2011
End Date
December 1 2014
Last Update
May 27 2016
Active Locations (106)
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1
Baptist Medical Center South
Montgomery, Alabama, United States, 36116
2
Scripps Clinic
La Jolla, California, United States, 92037
3
Scpmg/ Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
4
University Of Colorado Denver And Hospital
Aurora, Colorado, United States, 80045