Phase 2
Completed N=419
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
Source: ClinicalTrials.gov NCT01170962 ↗Enrolled (actual)
419
Serious AEs
6.7%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With Extended Rapid Virologic Response (eRVR) — 18.0; 19.7; 25.7; 35.8 percentage of participants
Summary
The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) |
18.0; 19.7; 25.7; 35.8; 0 | — |
| PRIMARY Percentage of Participants With 24-week Sustained Virologic Response (SVR24) |
18.8; 22.0; 24.3; 43.3; 0 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment |
14; 11; 3; 11; 12; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period |
6; 7; 0; 2; 2; 0 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) |
21.8; 21.2; 25.7; 38.8; 0 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) |
30.1; 34.1; 44.3; 56.7; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) |
19.5; 23.5; 25.7; 47.8; 0 | — |
| SECONDARY Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures |
2; 3; 1; 3; 2; 3 | — |
| SECONDARY Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures |
1; 1; 1; NA; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects chronically infected with HCV genotype 1
- Non-responder to prior therapy with peginterferon alfa and ribavirin
- HCV RNA viral load of 100, 00 IU/mL
- Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
- Body Mass Index (BMI) of 18 to 35 kg/m2
Exclusion Criteria
- Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Data sourced from ClinicalTrials.gov (NCT01170962). 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.