NCT01455090

Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

Detailed description

IND numbers: 79,599; 101,943

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	BMS-650032
DRUG	BMS-790052
DRUG	BMS-791325
DRUG	Ribavirin

Timeline

• Start date: 2011-11-30
• Primary completion: 2014-03-31
• Completion: 2015-07-31
• First posted: 2011-10-19
• Last updated: 2017-04-27

Locations

32 sites across 3 countries: United States, France, Puerto Rico