A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (UNITY 4)

October 27, 2020 updated by: Bristol-Myers Squibb
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

US National Institutes of Health Division of AIDs (DAIDS)

Study Type

Interventional

Enrollment (Actual)

199

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

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Local Institution
      • Busan, Korea, Republic of, 614-735
        • Local Institution
      • Gyeonggi-Do, Korea, Republic of, 480-717
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 463-707
        • Local Institution
      • Gyeongsangnam-do, Korea, Republic of, 626-770
        • Local Institution
      • Inchoen, Korea, Republic of, 405-760
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 138-736
        • Local Institution
      • Seoul, Korea, Republic of, 156-755
        • Local Institution
  • Russian Federation
      • Kazan, Russian Federation, 420140
        • Local Institution
      • Moscow, Russian Federation, 109240
        • Local Institution
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Local Institution
      • Kaohsiung, Taiwan, 807
        • Local Institution
      • Taichung, Taiwan, 40447
        • Local Institution
      • Taichung, Taiwan, 40705
        • Local Institution
      • Tainan, Taiwan, 704
        • Local Institution
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
      • Taoyuan, Taiwan, 333
        • 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

  • Child
  • 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:

  • Subject chronically infected with HCV genotype 1 (GT-1)
  • Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
  • Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV

Exclusion Criteria:

  • Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
  • Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

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: Arm 1 : DCV/ASV/BMS-791325
DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Drug: DCV/ASV/BMS-791325

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
Time Frame: Post treatment Week 12
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Post treatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort
Time Frame: Post treatment Week 12
Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LLOQ target detected or target not detected (LLOQ TD/TND).
Post treatment Week 12
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).
On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)
Percentage of treated participants with HCV RNA < LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.
On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
Time Frame: Up to post treatment week 4
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
Up to post treatment week 4
Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline
Time Frame: Up to post treatment week 4
Anemia was defined as hemoglobin < 10 g/dL on-treatment for subjects who had hemoglobin >= 10 g/dL at baseline.
Up to post treatment week 4
Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
Time Frame: Post treatment week 12
Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
Post treatment week 12
Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)
Time Frame: Post treatment Week 12
Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Post treatment Week 12
Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12
Time Frame: Post treatment Week 12
Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
Post treatment Week 12
Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Time Frame: Post treatment week 4
Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
Post treatment week 4
Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs
Time Frame: Up to post treatment week 4
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
Up to post treatment week 4
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Time Frame: Up to post treatment week 4
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.
Up to post treatment week 4

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 (Actual)

June 26, 2014

Primary Completion (Actual)

June 12, 2015

Study Completion (Actual)

September 9, 2015

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI443-123

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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