Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus

Treatments: Drug: Peginterferon Alfa-2a; Drug: Ribavirin; Drug: BMS-650032; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030432

AI447-016

2009-013652-69 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

Enrollment: 285 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
• Subjects chronically infected with HCV genotype 4 (Phase 2b only)
• HCV RNA viral load of ≥ 10*5* IU/mL at screening
• BMI of 18 - 35 kg/m² at screening

Exclusion criteria

• Cirrhosis (Phase 2a only)
• Decompensated cirrhosis (Phase 2b)
• Co-infection with HBV or HIV
• Hepatocellular carcinoma
• Prior treatment with anti-HCV drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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285 participants in 4 patient groups, including a placebo group

Phase 2a: Arm 1

Experimental group

Treatment:

Drug: Peginterferon Alfa-2a

Drug: BMS-650032

Drug: BMS-650032

Drug: Ribavirin

Drug: Peginterferon Alfa-2a

Drug: Ribavirin

Phase 2a: Arm 2

Placebo Comparator group

Treatment:

Drug: Peginterferon Alfa-2a

Drug: Placebo

Drug: Placebo

Drug: Ribavirin

Drug: Peginterferon Alfa-2a

Drug: Ribavirin

Drug: Placebo

Phase 2b: Arm 1

Experimental group

Treatment:

Drug: Peginterferon Alfa-2a

Drug: BMS-650032

Drug: Placebo

Drug: Placebo

Drug: BMS-650032

Drug: Ribavirin

Drug: Peginterferon Alfa-2a

Drug: Ribavirin

Drug: Placebo

Phase 2b: Arm 2

Placebo Comparator group

Treatment:

Drug: Peginterferon Alfa-2a

Drug: Placebo

Drug: Placebo

Drug: Ribavirin

Drug: Peginterferon Alfa-2a

Drug: Ribavirin

Drug: Placebo