A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Overview
- Phase
- Phase 2
- Intervention
- BMS-790052
- Conditions
- Hepatitis C Infection
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 51
- 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 is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients chronically infected with hepatitis C virus (HCV) genotype 1
- •HCV RNA viral load ≥10\*5\* IU/mL at screening
- •Naïve or nonresponsive to the current standard of care
Exclusion Criteria
- •Cirrhosis
- •Hepatocellular carcinoma
- •Coinfection with hepatitis B virus, HIV-1 or HIV-2
Arms & Interventions
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: BMS-790052
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: Peginterferon alfa-2b
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: Ribavirin
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: BMS-790052
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: Peginterferon alfa-2b
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: Ribavirin
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: Placebo
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: Peginterferon alfa-2b
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Intervention: Ribavirin
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Non-Responder
Intervention: BMS-790052
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Non-Responder
Intervention: Peginterferon alfa-2b
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Non-Responder
Intervention: Ribavirin
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Non-Responder
Intervention: BMS-790052
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Non-Responder
Intervention: Peginterferon alfa-2b
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Non-Responder
Intervention: Ribavirin
Outcomes
Primary Outcomes
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Time Frame: At Weeks 4 and 12 on treatment
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
Secondary Outcomes
- Percentage of Participants With Rapid Virologic Response (RVR)(At Week 4 on treatment)
- Percentage of Participants With Complete Early Virologic Response (cEVR)(At Week 12 on treatment)
- Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24(Follow-up Weeks 4, 12, and 24)
- Percentage of Participants With Virologic Failure(From on-treatment Week 1 to Follow-up Week 24)