Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C
2 other identifiers
interventional
276
18 countries
104
Brief Summary
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
Typical duration for phase_2
104 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
September 1, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
May 27, 2016
CompletedMay 27, 2016
April 1, 2016
3 years
September 1, 2011
August 19, 2015
April 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
SVR12 defined as HCV RNA\<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.
Week 12 (Follow-up period)
Secondary Outcomes (7)
Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Week 12 (Follow-up period)
Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4
Week 4
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Week 4 and 12
Percentage of Participants With Complete Early Virologic Response (cEVR)
Week 12
Percentage of Participants With End of the Treatment Response (EOTR)
End of the study (Week 24)
- +2 more secondary outcomes
Study Arms (3)
Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin
EXPERIMENTALPatients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks
Daclatasvir + PegIFNα-2a + Ribavirin
EXPERIMENTALPatients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks
Daclatasvir + Asunaprevir
EXPERIMENTALPatients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
- Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
- HCV RNA viral load detectable
You may not qualify if:
- Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
- Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
- Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV infection
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Baptist Medical Center South
Montgomery, Alabama, 36116, United States
Scripps Clinic
La Jolla, California, 92037, United States
Scpmg/ Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
University Of Colorado Denver And Hospital
Aurora, Colorado, 80045, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Uf Hepatology Research At Ctrb
Gainesville, Florida, 32610, United States
Schiff Center For Liver Diseases
Miami, Florida, 33136, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Digestive Disease Associates, P.A.
Catonsville, Maryland, 21228, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
North Shore Long Island Jewish Health System
Manhasset, New York, 11030, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Options Health Research, Llc
Tulsa, Oklahoma, 74104, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Baylor College Of Medicine
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Dean Clinic
Madison, Wisconsin, 53715, United States
Local Institution
Buenos Aires, Buenos Aires, 1119, Argentina
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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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Darlinghurst, New South Wales, 2010, Australia
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Kogarah, New South Wales, 2218, Australia
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Westmead Nsw, New South Wales, 2145, Australia
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Adelaide, South Australia, 5000, Australia
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Clayton Vic, Victoria, 3168, Australia
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Fitzroy, Victoria, 3065 VIC, Australia
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Heidelberg, Victoria, 3084, Australia
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Melbourne, Victoria, 3004, Australia
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Fremantle, Western Australia, 6160, Australia
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Perth, Western Australia, 6001, Australia
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Vancouver, British Columbia, V6Z 2K5, Canada
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Victoria, British Columbia, V8V 3P9, Canada
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Toronto, Ontario, M5G 2N2, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Toronto, Ontario, M6H 3M1, Canada
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Vaughan, Ontario, L4L 4Y7, Canada
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Montreal, Quebec, H2L 4P9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, Quebec, G3K 2P8, Canada
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Hvidovre, 2650, Denmark
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Bondy, 93143, France
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Clichy, 92118, France
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Créteil, 94000, France
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Créteil, 94010, France
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Lille, 59037, France
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Lyon, 69288, France
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Marseille, 13285, France
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Montpellier, 34295, France
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Nice, 06202, France
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Paris, 75571, France
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Paris, 75651, France
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Paris, 75679, France
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Toulouse, 31059, France
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VandÅ“uvre-lès-Nancy, 54511, France
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Villejuif, 94804, France
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Berlin, 12157, Germany
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Berlin, 13353, Germany
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Bonn, 53105, Germany
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Frankfurt, 60590, Germany
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Thesaloniki, 54639, Greece
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Dublin, Dublin, DUBLIN 7, Ireland
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Dublin, Dublin, Ireland
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Brescia, 25123, Italy
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Cisanello (pisa), 56124, Italy
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Messina, 98124, Italy
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Milan, 20121, Italy
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Pavia, 27100, Italy
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Roma, 00149, Italy
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Roma, 00161, Italy
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Torino, 10126, Italy
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Viale Del Policlinico, 155, 00161, Italy
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Guadalajara, Jalisco, 44160, Mexico
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Auckland, 92024, New Zealand
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Bialystok, 15-540, Poland
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Wroclaw, 50-349, Poland
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Busan, 602-715, South Korea
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Busan, 602-739, South Korea
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Busan, 614-735, South Korea
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Daegu, 700-721, South Korea
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Daegu, 705-703, South Korea
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Gyeonggi-do, 420-767, South Korea
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Seoul, 120-752, South Korea
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Seoul, 138-736, South Korea
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Barcelona, 08036, Spain
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Gothenburg, SE-416 85, Sweden
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Stockholm, 141 86, Sweden
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Taichung, 402, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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London, Greater London, NW3 2QG,, United Kingdom
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London, Greater London, SE5 9RS, United Kingdom
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London, Greater London, SW17 0QT, United Kingdom
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London, Greater London, W2 1NY, United Kingdom
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Manchester, Greater Manchester, M8 5RB, United Kingdom
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Glasgow, Lanarkshire, G12 0YN, 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 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 2, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
May 27, 2016
Results First Posted
May 27, 2016
Record last verified: 2016-04