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

Bristol-Myers Squibb (BMS) logo

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

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

Trial contacts and locations

40

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Data sourced from clinicaltrials.gov

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