Phase 3
Completed N=124
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
Source: ClinicalTrials.gov NCT01448044 ↗Enrolled (actual)
124
Serious AEs
8.1%
Results posted
Sep 2015
Primary outcomePrimary: Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) — 81.7; 42.9 Percentage of participants — p=<0.0001
Summary
The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) |
81.7; 42.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) |
53.7; 4.8; 89.0; 11.9; 91.5; 19.0 | — |
| SECONDARY Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels |
14.6; 0.0; 45.1; 9.5; 85.4; 11.9 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene |
95.5; 100.0; 75.0; 33.3; 80.0; 0.0 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died |
4; 3; 8; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants chronically infected with HCV Genotype 4
- HCV RNA viral load of ≥ 10,000 IU/mL
- No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
- Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted
Exclusion Criteria
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC)
- Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
Data sourced from ClinicalTrials.gov (NCT01448044). 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.