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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT01051414

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

10.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Infection	Drug: BMS-790052 Drug: BMS-650032	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2a Study of BMS-790052 and BMS-650032 in Combination Therapy With Japanese Subjects With Genotype 1 Chronic Hepatitis C (HCV) Virus Infection

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-790052 + BMS-650032	Drug: BMS-790052 Tablets, Oral, 60 mg, daily, 24 weeks Drug: BMS-650032 Tablets, Oral, 1200 mg, daily, 24 weeks

Arm

Intervention/Treatment

Experimental: BMS-790052 + BMS-650032

Drug: BMS-790052

Tablets, Oral, 60 mg, daily, 24 weeks

Drug: BMS-650032

Tablets, Oral, 1200 mg, daily, 24 weeks

Outcome Measures

Primary Outcome Measures

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

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 with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL [at both Weeks 4 and 12]
The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL [at follow-up Week 24]
Resistant variants associated with clinical failure [Weeks 4, 12, end of treatment and post-treatment Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects chronically infected with HCV Genotype 1
HCV RNA viral load of ≥ 105 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Hiroshima City	Hiroshima	Japan	734-0037
2	Local Institution	Sapporo-Shi	Hokkaido	Japan	060-0033
3	Local Institution	Kawasaki-Shi	Kanagawa	Japan	2138587
4	Local Institution	Minato-Ku	Tokyo	Japan	105-0001