A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1
Overview
- Phase
- Phase 2
- Intervention
- Daclatasvir
- Conditions
- Hepatitis C Infection
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 74
- Locations
- 12
- Primary Endpoint
- Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients chronically infected with hepatitis C virus (HCV) genotype 1
- •HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening
- •Treatment naive
Exclusion Criteria
- •Women of child-bearing potential
- •Cirrhosis
- •Coinfection with HIV or hepatitis B virus
Arms & Interventions
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
Intervention: Daclatasvir
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
Intervention: Peginterferon alpha-2a
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
Intervention: ribavirin
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
Intervention: Daclatasvir
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
Intervention: Peginterferon alpha-2a
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
Intervention: ribavirin
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
Intervention: Daclatasvir
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
Intervention: Peginterferon alpha-2a
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
Intervention: ribavirin
Placebo, Peginterferon alpha-2a, ribavirin (D)
Intervention: Placebo
Placebo, Peginterferon alpha-2a, ribavirin (D)
Intervention: Peginterferon alpha-2a
Placebo, Peginterferon alpha-2a, ribavirin (D)
Intervention: ribavirin
Outcomes
Primary Outcomes
Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
Time Frame: A Weeks 4 and 12
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Secondary Outcomes
- Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12(At Week 12)
- Percentage of Participants With Rapid Virologic Response (RVR) at Week 4(At Week 4)
- Percentage of Participants With Early Virologic Response (EVR) at Week 12(At Week 12)