Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
Hepatitis C Virus Infection
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection
Eligibility 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
Sites / Locations
- Baptist Medical Center South
- Scripps Clinic
- Scpmg/ Kaiser Permanente Los Angeles Medical Center
- University Of Colorado Denver And Hospital
- Yale University School Of Medicine
- Uf Hepatology Research At Ctrb
- Schiff Center For Liver Diseases
- Mercy Medical Center
- Digestive Disease Associates, P.A.
- Henry Ford Health System
- Washington University School Of Medicine
- North Shore Long Island Jewish Health System
- Duke University Medical Center
- Options Health Research, Llc
- University Of Pennsylvania
- Nashville Medical Research Institute
- Baylor College Of Medicine
- Alamo Medical Research
- Metropolitan Research
- Dean Clinic
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin
Daclatasvir + PegIFNα-2a + Ribavirin
Daclatasvir + Asunaprevir
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks