A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Hepatitis C Virus Genotype 1

Treatments: Drug: Placebo; Drug: BMS-824393; Drug: Peginterferon Alpha-2a; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01142700

AI451-004

2010-018702-36 (EudraCT Number)

Details and patient eligibility

About

Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naive subjects with genotype 1 chronic HCV
• HCV RNA ≥ 100,000 IU/mL at screening
• Seronegative for HIV and HBsAg
• Liver biopsy within prior 2 years demonstrating no cirrhosis

Exclusion criteria

• Any evidence of liver disease other than hepatitis C
• Diagnosed or suspected hepatocellular carcinoma
• Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
• Cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 5 patient groups, including a placebo group

BMS-824393 (10mg)

Experimental group

Description:

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Treatment:

Drug: Ribavirin

Drug: Peginterferon Alpha-2a

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

BMS-824393 (30 mg)

Experimental group

Description:

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Treatment:

Drug: Ribavirin

Drug: Peginterferon Alpha-2a

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

BMS-824393 (100 mg)

Experimental group

Description:

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Treatment:

Drug: Ribavirin

Drug: Peginterferon Alpha-2a

Drug: BMS-824393

Drug: BMS-824393

Drug: BMS-824393

Placebo

Placebo Comparator group

Description:

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Treatment:

Drug: Ribavirin

Drug: Peginterferon Alpha-2a

Drug: Placebo

Peginterferon alfa-2a plus Ribavirin

Other group

Description:

Weeks 13 - 48

Treatment:

Drug: Ribavirin

Drug: Peginterferon Alpha-2a