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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

NCT01142700 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2011-03-15

No results posted yet for this study

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.

Conditions

  • Chronic Hepatitis C Virus Genotype 1

Interventions

DRUG

BMS-824393

Capsule, Oral, 10 mg, once daily

DRUG

BMS-824393

Capsule, Oral, 30 mg, once daily

DRUG

BMS-824393

Capsule, Oral, 100 mg, once daily

DRUG

Placebo

Capsule, Oral, 0 mg, once daily

DRUG

Peginterferon Alpha-2a

Syringe, subcutaneous 180 mcg/0.5 mL, weekly

DRUG

Ribavirin

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01142700 on ClinicalTrials.gov