Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Pegylated-interferon alfa 2a; Drug: Ribavirin; Drug: Placebo matching BMS-790052; Drug: BMS-790052 (NS5A Replication Complex Inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01448044

AI444-042

2011-002793-23 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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152 participants in 2 patient groups, including a placebo group

BMS-790052 + PegIFNα-2a + Ribavirin

Experimental group

Description:

* 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

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon alfa 2a

Drug: BMS-790052 (NS5A Replication Complex Inhibitor)

Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin

Placebo Comparator group

Description:

* 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

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon alfa 2a

Drug: Placebo matching BMS-790052