Phase 2
Completed N=227
Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
Source: ClinicalTrials.gov NCT01428063 ↗Enrolled (actual)
227
Serious AEs
3.1%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) — 94.6 Percentage of participants
Summary
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) |
94.6 | — |
| SECONDARY Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) |
85.9; 90.0; 40.0; 100.0; 90.9; 76.9 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 |
72.7; 91.7; 70.0; 83.3; 90.9; 76.9 | — |
| SECONDARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) |
67.7; 87.5; 70.0; 83.3; 81.8; 76.9 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) |
87.9; 95.8; 90.0; 100.0; 90.9; 92.3 | — |
| SECONDARY Percentage of Participants With End of the Treatment Response (EOTR) |
85.9; 97.9; 90.0; 100.0; 90.9; 92.3 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) |
84.8; 95.8; 40.0; 100.0; 90.9; 76.9 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study |
4; 0; 0; 0; 2; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
- Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
- HCV RNA viral load detectable
Key Exclusion Criteria
- Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
- Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
- Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV infection
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Data sourced from ClinicalTrials.gov (NCT01428063). 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.