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Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

NCT01012895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2015-10-09

No results posted yet for this study

Summary

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

BMS-790052

Tablets, Oral, 60 mg, once daily, 24 weeks

DRUG

BMS-650032

Tablets, Oral, 600 mg, twice daily, 24 weeks

DRUG

BMS-650032

Tablets, Oral, 200mg, twice daily, 24 weeks

DRUG

BMS-650032

Tablets, Oral, 200 mg, once daily, 24 weeks

DRUG

Pegylated-interferon alfa-2a

Syringe, Subcutaneous Injection, 180 µg, once weekly

DRUG

Ribavirin

Tablets, Oral For subjects weighing \< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg Twice daily (\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-10-31
Completion
2014-02-28

Countries

  • United States
  • France
  • Puerto Rico

Study Locations

More Related Trials

Entities

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 NCT01012895 on ClinicalTrials.gov