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

A Randomized, Placebo-controlled, Phase 2a 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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01142700

Enrollment

Registered

2010-06-11

Start date

2010-07-31

Completion date

2010-12-31

Last updated

2011-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Virus Genotype 1

Brief summary

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.

Interventions

DRUGBMS-824393

Capsule, Oral, 10 mg, once daily

DRUGPlacebo

Capsule, Oral, 0 mg, once daily

DRUGPeginterferon Alpha-2a

Syringe, subcutaneous 180 mcg/0.5 mL, weekly

DRUGRibavirin

Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)	Week 4
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA	Week 4

Secondary

Measure	Time frame
Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA	Week 4
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA	Week 12
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable	Week 12 (SVR12)
Resistant variants associated with virologic failure	Week 4

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026