Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
NCT ID: NCT01616524
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
880 participants
INTERVENTIONAL
2012-07-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir
Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks
Arm 2: pegIFNλ + Ribavirin + Daclatasvir
Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Daclatasvir
Tablets, Oral, 60 mg, Once daily, 12 weeks
Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir
Pegylated interferon alfa-2a (pegIFNα-2a)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks
Interventions
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Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
Pegylated interferon alfa-2a (pegIFNα-2a)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Daclatasvir
Tablets, Oral, 60 mg, Once daily, 12 weeks
Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naïve to prior anti-HCV therapy
Exclusion Criteria
* Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
* Evidence of liver disease other than HCV
* Active substance abuse
* Evidence of decompensated cirrhosis
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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Mayo Clinic Arizona
Phoenix, Arizona, United States
Precision Research Institute, Llc
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
University Of California, San Francisco/Sf General Hospital
San Francisco, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Orlando Immunology Center
Orlando, Florida, United States
Orlando Infectious Disease Center
Orlando, Florida, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
The Queen'S Liver Center
Honolulu, Hawaii, United States
Henry Ford Hospital
Detroit, Michigan, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Consultants For Clinical Research
Cincinnati, Ohio, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
University Of Pittsburgh Medical Center, Ctr For Liver Diseases
Pittsburgh, Pennsylvania, United States
Texas Clinical Research Institute, Llc
Arlington, Texas, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, United States
Clinical Research Centers Of America
Murray, Utah, United States
Local Institution
Autonoma, Buenos Aires, Argentina
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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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Mar del Plata, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Prov de Santa Fe, Santa Fe Province, Argentina
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Camperdown, New South Wales, Australia
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Concord, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
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Randwick, New South Wales, Australia
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Westmead Nsw, New South Wales, Australia
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Brisbane, Queensland, Australia
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Greenslopes, Queensland, Australia
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Herston, Queensland, 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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Melbourne, Victoria, Australia
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Parville, Victoria, Australia
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Fremantle, Western Australia, Australia
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Santiago, Santiago Metropolitan, Chile
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Hus, , Finland
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Clichy, , France
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Créteil, , France
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Montpellier, , France
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Nice, , France
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Athens, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Tai Po, , Hong Kong
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Novara, , Italy
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Fukuoka, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Hiroshima, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Tsuchiura-shi, Ibaraki, Japan
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Takamatsu, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kawasaki-shi, Kanagawa, Japan
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Miyazaki, Miyazaki, Japan
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Okayama, Okayama-ken, Japan
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Saga, Saga-ken, Japan
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Iruma-gun, Saitama, Japan
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Saitama, Saitama, Japan
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Bunkyo-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Musashino-shi, Tokyo, Japan
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Wakayama, Wakayama, Japan
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Distrito Federal, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Tlalpan, Mexico City, Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Amsterdam, , Netherlands
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Leiden, , Netherlands
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Auckland, , New Zealand
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Chelyabinsk, , Russia
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Irkutsk, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Smolensk, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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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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Gyeonggi-do, , South Korea
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Gyeongsangnam-do, , South Korea
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Incheon, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Yunlin, , Taiwan
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Hull, Humberside, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
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Birmingham, West Midlands, United Kingdom
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London, , 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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2011-004885-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI452-017
Identifier Type: -
Identifier Source: org_study_id
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