Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
NCT ID: NCT01428063
Last Updated: 2016-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
276 participants
INTERVENTIONAL
2011-09-30
2014-12-31
Brief Summary
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Detailed Description
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* Parallel: for all patients entering the trial
* Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study
* Peginterferon alfa-2a
* Ribavirin
* Daclatasvir
* Asunaprevir
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin
Patients 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
Asunaprevir
Pegylated interferon alfa-2a
Ribavirin
Daclatasvir + PegIFNα-2a + Ribavirin
Patients 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
Pegylated interferon alfa-2a
Ribavirin
Daclatasvir + Asunaprevir
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
Daclatasvir
Asunaprevir
Interventions
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Daclatasvir
Asunaprevir
Pegylated interferon alfa-2a
Ribavirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
* HCV RNA viral load detectable
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Baptist Medical Center South
Montgomery, Alabama, United States
Scripps Clinic
La Jolla, California, United States
Scpmg/ Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
University Of Colorado Denver And Hospital
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Uf Hepatology Research At Ctrb
Gainesville, Florida, United States
Schiff Center For Liver Diseases
Miami, Florida, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates, P.A.
Catonsville, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
North Shore Long Island Jewish Health System
Manhasset, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Baylor College Of Medicine
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Prov. Buenos Aires, Buenos Aires, Argentina
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Prov de Santa Fe, Santa Fe Province, Argentina
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Darlinghurst, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Westmead Nsw, New South Wales, Australia
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Adelaide, South Australia, Australia
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Clayton Vic, Victoria, Australia
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Fitzroy, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Fremantle, Western Australia, Australia
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Perth, Western Australia, Australia
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Graz, , Austria
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Vienna, , Austria
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Vaughan, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Hvidovre, , Denmark
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Bondy, , France
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Clichy, , France
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Créteil, , France
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Créteil, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Thesaloniki, , Greece
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Dublin, Dublin, Ireland
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Dublin, Dublin, Ireland
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Brescia, , Italy
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Cisanello (pisa), , Italy
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Messina, , Italy
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Milan, , Italy
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Pavia, , Italy
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Roma, , Italy
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Roma, , Italy
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Torino, , Italy
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Viale Del Policlinico, 155, , Italy
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Guadalajara, Jalisco, Mexico
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Auckland, , New Zealand
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Bialystok, , Poland
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Wroclaw, , Poland
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Busan, , South Korea
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Busan, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Daegu, , South Korea
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Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-000836-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-026
Identifier Type: -
Identifier Source: org_study_id
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