Phase 2
Completed N=48
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
Hepatitis C Infection
Source: ClinicalTrials.gov NCT00874770 ↗
Enrolled (actual)
48
Serious AEs
6.3%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 — 41.7; 83.3; 75; 8.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 |
41.7; 83.3; 75; 8.3 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 |
41.7; 91.7; 83.3; 8.3 | — |
| SECONDARY Percentage of Participants With Early Virologic Response (EVR) at Week 12 |
75; 100; 83.3; 66.7 | — |
| SECONDARY Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 |
58.3; 83.3; 83.3; 41.7 | — |
Eligibility Criteria
Key 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
Key Exclusion Criteria
- Women of child-bearing potential
- Cirrhosis
- Coinfection with HIV or hepatitis B virus
Data sourced from ClinicalTrials.gov (NCT00874770). 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.