UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

October 9, 2015 updated by: Bristol-Myers Squibb

A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C

To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
416

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
      • Clayton, Australia
        • Local Institution
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Local Institution
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
    • Western Australia
      • Fremantle, Western Australia, Australia, 6959
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Local Institution
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Local Institution
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Local Institution
      • Victoria, British Columbia, Canada, V8V 3P9
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Local Institution
      • Toronto, Ontario, Canada, M6H 3M1
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • Local Institution
      • Montreal, Quebec, Canada, H2X 2P4
        • Local Institution
      • Montreal, Quebec, Canada, H3A 1T1
        • Local Institution
  • France
      • Clichy, France, 92110
        • Local Institution
      • Limoges Cedex, France, 87042
        • Local Institution
      • Montpellier, France, 34295
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
      • Pessac, France, 33604
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion De Investigacion de Diego
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University Of Colorado Denver & Hospital
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Med Center
    • Maryland
      • Catonsville, Maryland, United States, 21228
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins Medical Institutions
    • Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Care Clinic
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Vineland, New Jersey, United States, 08360
        • The Gastroenterology Group of South Jersey
    • New York
      • Binghamton, New York, United States, 13903
        • Binghamton Gastroenterology Associates
      • Bronx, New York, United States, 10468
        • James J Peters VAMC
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley, PC
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, PA
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Statesville, North Carolina, United States, 28677
        • Carolinas Center For Liver Disease
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates, LLC
      • Winston-salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • Lehigh Valley Health Network
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15213
        • University Of Pittsburgh Medical Center, Ctr For Liver Diseases
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research PLLC
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • Baylor St. Luke's Medical Center
      • San Antonio, Texas, United States, 78215
        • Texas Liver Institute
    • Virginia
      • Alexandria, Virginia, United States, 22306
        • Mt Vernon Endoscopy Center
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Newport News, Virginia, United States, 23602
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 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:

  • Subjects chronically infected with HCV genotype 1
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
  • Treatment-experienced subjects are eligible

Exclusion Criteria:

  • Evidence of cirrhosis
  • Liver or any other organ transplant
  • Current or known history of cancer within 5 years prior to enrollment
  • Documented or suspected HCC
  • Evidence of decompensated liver

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A 1: DCV/ASV/BMS-791325 in treatment-naive subjects
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
Drug: DCV/ASV/BMS-791325
Experimental: A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
Drug: DCV/ASV/BMS-791325

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12
Time Frame: Post-Treatment Week 12
SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12
Post-Treatment Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects in the experienced cohort with SVR12
Time Frame: Follow up Week 12
Follow up Week 12
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND
Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment 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) and 24 (SVR24)
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND
Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24
On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24
Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort
Time Frame: Up to post treatment week 4 (±7 days)
Up to post treatment week 4 (±7 days)
Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort
Time Frame: Up to post treatment week 4 (±7 days)
Up to post treatment week 4 (±7 days)
Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort
Time Frame: Up to post treatment week 4 (±7 days)
Up to post treatment week 4 (±7 days)
Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b
Time Frame: Post treatment week 12
Post treatment week 12
Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)
Time Frame: Post treatment week 12
Post treatment week 12
Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis
Time Frame: Post treatment week 12
Post treatment week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI443-102
  • 2013-002468-20 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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