Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2011 |
End Date: | January 2014 |
A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4
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).
Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin
(RBV) versus placebo/PegIFNα-2a/RBV).
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
We found this trial at
5
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