Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring hepatitis C virus
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
Sites / Locations
- Scti Research Foundation
- Umass Memorial Medical Center
- University Gastroenterology
- Metropolitan Research
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BMS-790052 + PegIFNα-2a + Ribavirin
Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin
BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response
Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks