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

NCT01030432 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2015-10-09

No results posted yet for this study

Summary

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).

Conditions

  • Hepatitis C Virus

Interventions

DRUG

BMS-650032

Tablets, Oral, 200 mg, Twice Daily, 48 weeks

DRUG

BMS-650032

Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response

DRUG

Placebo

Tablets, Oral, 0 mg, twice daily, 48 weeks

DRUG

Placebo

Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12

DRUG

Placebo

Tablets, Oral, 0 mg, twice daily 24 weeks

DRUG

Peginterferon Alfa-2a

Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks

DRUG

Peginterferon Alfa-2a

Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response

DRUG

Ribavirin

Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks

DRUG

Ribavirin

Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Argentina
  • France
  • Germany
  • Ireland
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01030432 on ClinicalTrials.gov