Phase 2
Completed N=42
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
Hepatitis C Infection
Source: ClinicalTrials.gov NCT01017575 ↗
Enrolled (actual)
42
Serious AEs
4.8%
Results posted
Sep 2015
Primary outcomePrimary: Percentage of Participants With Extended Rapid Virologic Response (eRVR) — 12.5; 66.7; 62.5; 62.5 percentage of participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) |
12.5; 66.7; 62.5; 62.5; 77.8 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) |
12.5; 77.8; 62.5; 62.5; 88.9 | — |
| SECONDARY Percentage of Participants With a Complete Early Virologic Response (cEVR) |
62.5; 88.9; 100; 87.5; 88.9 | — |
| SECONDARY Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 |
75; 88.9; 100; 50; 77.8; 75 | — |
Eligibility Criteria
Key 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
Key Exclusion Criteria
- Cirrhosis
- HCC
- Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
Data sourced from ClinicalTrials.gov (NCT01017575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.