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

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Chronic Hepatitis C Virus Genotype 1

Interventions

BMS-824393DRUG

Capsule, Oral, 10 mg, once daily

BMS-824393DRUG

Capsule, Oral, 30 mg, once daily

BMS-824393DRUG

Capsule, Oral, 100 mg, once daily

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (11)

Local Institution

Coronado, California, United States

Research And Education, Inc.

San Diego, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

Time frame: Week 4

Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

Time frame: Week 12

Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

Time frame: Week 24

Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

Time frame: Week 48

Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA

Time frame: Week 4

Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA

Time frame: Week 12

Secondary Outcomes

Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA

Time frame: Week 4

Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA

Time frame: Week 12

Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable

Time frame: Week 12 (SVR12)

Data from ClinicalTrials.gov

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