An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

Phase 2

Completed

• Conditions: Hepatitis C Infection
• Interventions: Drug: BMS-790052; Drug: BMS-650032

• Registration Number: NCT01051414
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Study Start: 2010-04
• Primary Completion: 2011-09
• Study Completion: 2012-05
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-09
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Subjects chronically infected with HCV Genotype 1
• HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening

Exclusion Criteria

• Subjects with evidence of liver cirrhosis
• Evidence of HCC
• Co-infection with hepatitis B virus, HIV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-790052 + BMS-650032	BMS-650032	-
BMS-790052 + BMS-650032	BMS-790052	-

Primary Outcome Measures

Name	Time	Method
Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs	Week 4
Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12)	Post-treatment Week 12

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL	at both Weeks 4 and 12
Resistant variants associated with clinical failure	Weeks 4, 12, end of treatment and post-treatment Week 24
The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities	Weeks 4, 12, end of treatment and post-treatment Week 24
The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL	Week 4
The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL	at follow-up Week 24

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Minato-Ku, Tokyo, Japan