A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Overview
- Phase
- Phase 2
- Intervention
- Daclatasvir
- Conditions
- Hepatitis C Infection
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Extended Rapid Virologic Response (eRVR)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects chronically infected with hepatitis C virus (HCV) genotype 1
- •HCV RNA viral load ≥ 10\*5\* IU/mL (100,000 IU/mL) at screening
- •The current standard of care naïve or non-responder
Exclusion Criteria
- •Cirrhosis
- •Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
Arms & Interventions
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Daclatasvir
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Peginterferon alfa-2a
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Ribavirin
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Daclatasvir
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Peginterferon alfa-2a
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Ribavirin
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Placebo
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Peginterferon alfa-2a
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Intervention: Ribavirin
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
Intervention: Daclatasvir
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
Intervention: Peginterferon alfa-2a
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
Intervention: Ribavirin
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
Intervention: Daclatasvir
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
Intervention: Peginterferon alfa-2a
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
Intervention: Ribavirin
Outcomes
Primary Outcomes
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Time Frame: From Week 4 up to Week 12
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
Secondary Outcomes
- Percentage of Participants With Rapid Virologic Response (RVR)(Week 4)
- Percentage of Participants With a Complete Early Virologic Response (cEVR)(Week 12)
- Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24(Follow up Week 12, Follow up Week 24)