UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

September 16, 2015 updated by: Bristol-Myers Squibb

A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C

The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Limit of Quantitation (LOQ)

Ribonucleic acid (RNA)

End of Treatment (EOT)

Triple Direct Acting Antivirals (3DAA)

Study Type

Interventional

Enrollment (Actual)

297

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
      • Fukui, Japan, 9188503
        • Local Institution
      • Kumamoto, Japan, 8628655
        • Local Institution
      • Miyazaki, Japan, 8800003
        • Local Institution
      • Nishinomiya-shi, Japan, 6638501
        • Local Institution
      • Saga, Japan, 8408571
        • Local Institution
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4678602
        • Local Institution
      • Nagoya-shi, Aichi, Japan, 466-8560
        • Local Institution
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8108563
        • Local Institution
      • Kurume-shi, Fukuoka, Japan, 8300011
        • Local Institution
    • Gifu
      • Gifu-shi, Gifu, Japan, 5008513
        • Local Institution
      • Ogaki-shi, Gifu, Japan, 5038502
        • Local Institution
    • Gunma
      • Takasaki, Gunma, Japan, 3700829
        • Local Institution
    • Hiroshima
      • Hiroshima-Shi, Hiroshima, Japan, 7348551
        • Local Institution
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0600033
        • Local Institution
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 6500047
        • 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
      • Yokohama, Kanagawa, Japan, 2320024
        • Local Institution
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 6028566
        • Local Institution
    • Nara
      • Kashihara, Nara, Japan, 6348522
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution
    • Osaka
      • Osaka-shi, Osaka, Japan, 5438555
        • 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, 3500495
        • Local Institution
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138655
        • Local Institution
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 1808610
        • Local Institution
      • Shinjuku-Ku, Tokyo, Japan, 1608582
        • Local Institution
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 9909585
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Males and females, ≥ 20 years of age
  • Subjects chronically infected with HCV GT-1
  • HCV RNA viral load of ≥ 100,000 IU/mL

Exclusion Criteria:

  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV
DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
Drug: DCV 3DAA
Other Names:
  • Daclatasvir 30 mg /Asunaprevir 200 mg /BMS-791325 75 mg fixed dose combination
Other: Placebo for Daclatasvir
Other: Placebo for Asunaprevir
Active Comparator: Arm 2: DCV/ASV + Placebo for DCV 3DAA
Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
Drug: Daclatasvir
Drug: Asunaprevir
Other: Placebo for DCV 3DAA
Experimental: DCV 3DAA
DCV 3DAA (open label) Tablet orally twice daily for 12 weeks
Drug: DCV 3DAA
Other Names:
  • Daclatasvir 30 mg /Asunaprevir 200 mg /BMS-791325 75 mg fixed dose combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12
Time Frame: After 12 weeks of the last dose
After 12 weeks of the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV
Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325
Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24
Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities
Time Frame: Approximately 48 weeks
based on the US National Institutes of Health Division of AIDs (DAIDS) criteria
Approximately 48 weeks
The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb ≥ 10 g/dL at baseline
Time Frame: Approximately 48 weeks
Approximately 48 weeks
The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b
Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status
Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12
Time Frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
On-treatment safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities on DAIDS criteria
Time Frame: Approximately 48 weeks
Approximately 48 weeks

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.

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

April 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI443-117

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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