Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection (COMMAND-3)

April 28, 2016 updated by: Bristol-Myers Squibb

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Allocation: Randomized Stratified

Study Type

Interventional

Enrollment (Actual)

605

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

  • Argentina
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • Local Institution
      • Prov. Buenos Aires, Buenos Aires, Argentina, 1629
        • Local Institution
    • Santa Fe
      • Prov De Santa Fe, Santa Fe, Argentina, 2000
        • Local Institution
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution
      • Penrith, New South Wales, Australia, 2750
        • Local Institution
      • Westmead Nsw, New South Wales, Australia, 2145
        • Local Institution
    • Queensland
      • Greenslopes Qld, Queensland, Australia, 4120
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Victoria
      • Fitzroy, Victoria, Australia, 3065 VIC
        • Local Institution
      • Prahran, Victoria, Australia, 3181
        • Local Institution
  • Austria
      • Linz, Austria, 4010
        • Local Institution
      • Wien, Austria, 1090
        • Local Institution
      • Wien, Austria, 1160
        • Local Institution
  • Brazil
      • Sao Paulo, Brazil, 04023-062
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 2B7
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Local Institution
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution
      • Toronto, Ontario, Canada, M5G 2N2
        • Local Institution
  • Denmark
      • Hvidovre, Denmark, 2650
        • Local Institution
      • Odense, Denmark, 5000
        • Local Institution
  • France
      • Besancon, France, 25000
        • Local Institution
      • Bondy Cedex, France, 93143
        • Local Institution
      • Grenoble Cedex 09, France, 38043
        • Local Institution
      • Lille Cedex, France, 59037
        • Local Institution
      • Paris Cedex 12, France, 75571
        • Local Institution
      • Paris Cedex 13, France, 75651
        • Local Institution
      • Pessac, France, 33600
        • Local Institution
      • Strasbourg, France, 67090
        • Local Institution
  • Germany
      • Berlin, Germany, 13353
        • Local Institution
      • Berlin, Germany, 10969
        • Local Institution
      • Essen, Germany, 45122
        • Local Institution
      • Frankfurt, Germany, 60590
        • Local Institution
      • Freiburg, Germany, 79106
        • Local Institution
      • Hamburg, Germany, 20246
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Koeln, Germany, 50937
        • Local Institution
  • Israel
      • Haifa, Israel, 31096
        • Local Institution
      • Nazareth, Israel, 16100
        • Local Institution
      • Tel Aviv, Israel, 64239
        • Local Institution
      • Zefat, Israel, 13110
        • Local Institution
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution
      • Cisanello (pisa), Italy, 56124
        • Local Institution
      • Firenze, Italy, 50134
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Torino, Italy, 10100
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-540
        • Local Institution
      • Chorzow, Poland, 41-500
        • Local Institution
      • Kielce, Poland, 25-317
        • Local Institution
      • Myslowice, Poland, 41-400
        • Local Institution
      • Raciborz, Poland, 47-400
        • Local Institution
      • Wroclaw, Poland, 50-220
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 109240
        • Local Institution
      • Moscow, Russian Federation, 119991
        • Local Institution
      • Moscow, Russian Federation, 121170
        • Local Institution
  • Spain
      • Alcorcon, Spain, 28922
        • Local Institution
      • Barcelona, Spain, 08036
        • Local Institution
      • Barcelona, Spain, 08003
        • Local Institution
      • Valencia, Spain, 46010
        • Local Institution
  • Switzerland
      • Zurich, Switzerland, 8091
        • Local Institution
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Local Institution
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Local Institution
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The Kirklin Clinic
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8019
        • Yale University School Of Medicine
    • Florida
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Atlanta Medical Center
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
        • University of Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Minnesota Gastroenterology, P.A.
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • Saint Louis University Gastroenterology & Hepatology
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
        • University Of North Carolina At Chapel Hill School Of Med
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • Texas
      • Ft. Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Research Specialists of Texas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
  • HCV RNA viral load ≥10,000 IU/mL
  • No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
  • No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
  • Body mass index of 18 to 35 kg/m^2
  • Negative for HIV and hepatitis B virus

Key Exclusion Criteria:

  • Evidence of decompensated liver disease
  • Evidence of medical condition other than HCV contributing to chronic liver disease

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daclatasvir + Peginterferon alfa-2a + Ribavirin
Drug: Daclatasvir
Film-coated tablet, oral, 60 mg, once daily, 24 weeks
Other Names:
  • BMS-790052
Drug: Peginterferon alfa-2a
Solution for injection, subcutaneous injection, 180 μg, weekly
Other Names:
  • Pegasys®
Drug: Ribavirin
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Other Names:
  • Copegus®
Experimental: Telaprevir + Peginterferon alfa-2a + Ribavirin
Drug: Peginterferon alfa-2a
Solution for injection, subcutaneous injection, 180 μg, weekly
Other Names:
  • Pegasys®
Drug: Ribavirin
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Other Names:
  • Copegus®
Drug: Telaprevir
Film-coated tablet, oral, 750 mg, 3 times daily
Other Names:
  • Incivek®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Time Frame: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
Week 12 (Follow-up period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
Time Frame: Week 4
RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.
Week 4
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
Time Frame: Week 4, Week 12
eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.
Week 4, Week 12
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
Time Frame: Week 12
cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.
Week 12
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
Time Frame: Week 24 (Follow-up period)
SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.
Week 24 (Follow-up period)
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Time Frame: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.
Week 12 (Follow-up period)

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

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-052
  • 2011-004237-14 (EudraCT Number)

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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