A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

September 23, 2015 updated by: Bristol-Myers Squibb

A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

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
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4668560
        • Local Institution
    • Chiba
      • Chiba-shi, Chiba, Japan, 2608677
        • Local Institution
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8108563
        • Local Institution
      • Kurume, Fukuoka, Japan, 8300011
        • Local Institution
    • Gifu
      • Ogaki-shi, Gifu, Japan, 5038502
        • Local Institution
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 7340037
        • Local Institution
    • Hokkaido
      • Sapporo-Shi, Hokkaido, Japan, 0600033
        • Local Institution
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan, 6608511
        • Local Institution
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9208641
        • Local Institution
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 7608557
        • Local Institution
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8908520
        • Local Institution
    • Kanagawa
      • Kawasaki-Shi, Kanagawa, Japan, 2138587
        • Local Institution
    • Miyagi
      • Sendai-Shi, Miyagi, Japan, 9808574
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution
    • Osaka
      • Osaka-sayama-shi, Osaka, Japan, 5898511
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5458586
        • Local Institution
      • Suita, Osaka, Japan, 5640013
        • Local Institution
      • Suita-shi, Osaka, Japan, 5650871
        • Local Institution
    • Saitama
      • Iruma-Gun, Saitama, Japan, 350-0495
        • Local Institution
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 1138655
        • Local Institution
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 1808610
        • Local Institution
      • Shinagawa-ku, Tokyo, Japan, 1428666
        • Local Institution
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 4093898
        • 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:

  • Chronic HCV-1b infected patient
  • HCV RNA viral load of ≥ 100,000 IU/mL at screening
  • Ages 20 to 75 years
  • Non-responder to Interferon plus Ribavirin therapy
  • Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

Exclusion Criteria:

Patients who have -

  • Hepatocellular carcinoma
  • Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
  • Severe or uncontrollable complication

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: Daclatasvir + Asunaprevir
Drug: BMS-790052 (Daclatasvir)
Tablets, Oral, 60mg, Once daily, 24 weeks
Drug: BMS-650032 (Asunaprevir)
Capsules, Oral, 100mg, Twice daily, 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiviral activity, as determined by the proportion of subjects with SVR24
Time Frame: After 24 weeks of the last dose
SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)
After 24 weeks of the last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected
Time Frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12
Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12
Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected
Time Frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24
Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24
Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade
Time Frame: End of treatment plus 7 days
End of treatment plus 7 days
Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]
Time Frame: Follow-up Week 24
Follow-up 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

Helpful Links

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

January 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 23, 2011

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI447-026

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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