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

September 23, 2015 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hiroshima
      • Hiroshima City, Hiroshima, Japan, 734-0037
        • Local Institution
    • Hokkaido
      • Sapporo-Shi, Hokkaido, Japan, 060-0033
        • Local Institution
    • Kanagawa
      • Kawasaki-Shi, Kanagawa, Japan, 2138587
        • Local Institution
    • Tokyo
      • Minato-Ku, Tokyo, Japan, 105-0001
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Week 4
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)
Time Frame: Post-treatment Week 12
Post-treatment Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI447-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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