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Ph IIA Study (SOC +/- NS5B)

NCT01193361 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-10-09

No results posted yet for this study

Summary

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects

Conditions

  • Hepatitis C Virus

Interventions

DRUG

BMS-791325

Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response

DRUG

BMS-791325

Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response

DRUG

Placebo

Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response

DRUG

Peg-interferon alfa-2a

Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response

DRUG

Ribavirin

Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 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
2010-10-31
Primary Completion
2011-06-30
Completion
2012-11-30

Countries

  • United States

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 NCT01193361 on ClinicalTrials.gov