Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
COMMAND-3
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
2 other identifiers
interventional
605
15 countries
88
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2012
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
June 3, 2016
CompletedJune 3, 2016
April 1, 2016
1.9 years
December 13, 2011
August 17, 2015
April 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
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 Outcomes (5)
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
Week 4
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
Week 4, Week 12
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
Week 12
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
Week 24 (Follow-up period)
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Week 12 (Follow-up period)
Study Arms (2)
Daclatasvir + Peginterferon alfa-2a + Ribavirin
EXPERIMENTALTelaprevir + Peginterferon alfa-2a + Ribavirin
EXPERIMENTALInterventions
Film-coated tablet, oral, 60 mg, once daily, 24 weeks
Film-coated tablet, oral, 750 mg, 3 times daily
Solution for injection, subcutaneous injection, 180 μg, weekly
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of decompensated liver disease
- Evidence of medical condition other than HCV contributing to chronic liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
The Kirklin Clinic
Birmingham, Alabama, 35294, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Va Long Beach Healthcare System
Long Beach, California, 90822, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520-8019, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Atlanta Medical Center
Atlanta, Georgia, 30312, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, 30060, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University Of Maryland
Baltimore, Maryland, 21201-1595, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, 55114, United States
Saint Louis University Gastroenterology & Hepatology
St Louis, Missouri, 63104, United States
Weill Cornell Medical College
New York, New York, 10021, United States
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, 27599-7584, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Baylor College Of Medicine
Houston, Texas, 77030, United States
Research Specialists Of Texas
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1121ABE, Argentina
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Ciudad de Buenos Aires, Buenos Aires, C1181ACH, Argentina
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Prov. Buenos Aires, Buenos Aires, 1629, Argentina
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Prov de Santa Fe, Santa Fe Province, 2000, Argentina
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Camperdown, New South Wales, 2050, Australia
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Penrith, New South Wales, 2750, Australia
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Westmead Nsw, New South Wales, 2145, Australia
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Greenslopes Qld, Queensland, 4120, Australia
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Adelaide, South Australia, 5000, Australia
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Fitzroy, Victoria, 3065 VIC, Australia
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Prahran, Victoria, 3181, Australia
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Linz, 4010, Austria
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Vienna, 1090, Austria
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Vienna, 1160, Austria
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São Paulo, São Paulo, 04023-062, Brazil
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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Winnipeg, Manitoba, R3E 3P4, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2N2, Canada
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Hvidovre, 2650, Denmark
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Odense, 5000, Denmark
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Besançon, 25000, France
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Bondy, 93143, France
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Grenoble, 38043, France
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Lille, 59037, France
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Paris, 75571, France
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Paris, 75651, France
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Pessac, 33600, France
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Strasbourg, 67090, France
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Berlin, 10969, Germany
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Berlin, 13353, Germany
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Cologne, 50937, Germany
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Essen, 45122, Germany
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Frankfurt, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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Haifa, 31096, Israel
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Nazareth, 16100, Israel
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Safed, 13110, Israel
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Tel Aviv, 64239, Israel
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Bergamo, 24127, Italy
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Cisanello (pisa), 56124, Italy
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Florence, 50134, Italy
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Napoli, 80131, Italy
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Torino, 10100, Italy
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Bialystok, 15-540, Poland
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Chorzów, 41-500, Poland
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Kielce, 25-317, Poland
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Mysłowice, 41-400, Poland
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Racibórz, 47-400, Poland
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Wroclaw, 50-220, Poland
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Moscow, 109240, Russia
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Moscow, 119991, Russia
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Moscow, 121170, Russia
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Alcorcón, 28922, Spain
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Barcelona, 08003, Spain
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Barcelona, 08036, Spain
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Valencia, 46010, Spain
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Zurich, 8091, Switzerland
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London, Greater London, SE5 9RS, United Kingdom
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Edinburgh, Scotland, EH4 2XU, United Kingdom
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Glasgow, Scotland, G12 0YN, United Kingdom
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Birmingham, West Midlands, B15 2TH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 15, 2011
Study Start
January 1, 2012
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
June 3, 2016
Results First Posted
June 3, 2016
Record last verified: 2016-04