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

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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).


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
sites
San Clemente, California 92673
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San Clemente, CA
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Annandale, Virginia 22031
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Annandale, VA
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Bondy Cedex, 93143
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Bondy Cedex,
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Providence, Rhode Island 02905
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Providence, RI
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Worcester, Massachusetts 01605
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Worcester, MA
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