Phase 2
Completed N=45
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
Hepatitis C Infection
Source: ClinicalTrials.gov NCT01016912 ↗
Enrolled (actual)
45
Serious AEs
2.2%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With Extended Rapid Virologic Response (eRVR) — 0; 66.7; 80.0; 55.6 percentage of participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) |
0; 66.7; 80.0; 55.6; 22.2 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) |
0; 77.8; 80.0; 55.6; 33.3 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) |
62.5; 77.8; 100.0; 55.6; 55.6 | — |
| SECONDARY Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 |
75.0; 66.7; 90.0; 22.2; 33.3; 62.5 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
37.5; 33.3; 10.0; 77.8; 66.7; 12.5 | — |
Eligibility Criteria
Key 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
Key Exclusion Criteria
- Cirrhosis
- Hepatocellular carcinoma
- Coinfection with hepatitis B virus, HIV-1 or HIV-2
Data sourced from ClinicalTrials.gov (NCT01016912). 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.