Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
NCT ID: NCT01598090
Last Updated: 2019-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
881 participants
INTERVENTIONAL
2012-06-14
2015-05-15
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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Part A: Peginterferon Lambda-1a + RBV + TVR
Peginterferon Lambda-1a
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR
Peginterferon Lambda-1a
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR
Peginterferon Alfa-2a
Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Interventions
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Peginterferon Lambda-1a
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
Peginterferon Alfa-2a
Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naives to prior anti-HCV therapy \[Interferon (IFN) and direct antiviral agent (DAA) based\]
* Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA \> 25IU/mL after discontinuation of treatment). Capped at 20%
* HCV RNA ≥ 100,000 IU/mL
* Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
* Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
* Men or women, 18-70 years of age
Exclusion Criteria
* Current or past evidence of decompensation
* Conditions that preclude the use of Alfa/RBV/TVR per respective labels
* Diagnosed or suspected hepatocellular carcinoma
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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Birmingham Gastroenterology Associates, P.C.
Birmingham, Alabama, United States
The Kirklin Clinic
Birmingham, Alabama, United States
The University Of Alabama Of Birmingham
Birmingham, Alabama, United States
Anaheim Clinical Trials Llc
Anaheim, California, United States
Sc Clinical Research, Inc.
Garden Grove, California, United States
Va Long Beach Healthcare System
Long Beach, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Va Greater Los Angeles Healthcare System
Los Angeles, California, United States
University Of California, San Francisco/Sf General Hospital
San Francisco, California, United States
South Bay Ge Medical Group
Torrance, California, United States
Orlando Va Medical Center
Orlando, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States
Gastrointestinal Specialists Of Georgia Pc
Marietta, Georgia, United States
Mercy Medical Center
Baltimore, Maryland, United States
Saint Luke'S Transplant Specialists
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Gastro One
Germantown, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Clinical Research Centers Of America
Murray, Utah, United States
Metropolitan Research
Annandale, Virginia, United States
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
Newport News, Virginia, United States
Digestive And Liver Disease Specialists
Norfolk, Virginia, United States
Local Institution
Graz, , Austria
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Linz, , Austria
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Salvador, Estado de Bahia, Brazil
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Salvador, Estado de Bahia, Brazil
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Curitiba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Botucatu, São Paulo, Brazil
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Botucatu, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
University Of Calgary
Calgary, Alberta, Canada
Liver And Intestinal Research Centre (Lair)
Vancouver, British Columbia, Canada
Gastrointestinal Research Institute (G.I.R.I.)
Vancouver, British Columbia, Canada
Percuro Clinical Research Ltd
Victoria, British Columbia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Local Institution
Hradec Králové, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Orléans, , France
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Poitiers, , France
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Rennes, , France
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Rouen, , France
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Toulouse, , France
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Villejuif, , France
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Berlin, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Münster, , Germany
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Ulm, , Germany
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Nazareth, , Israel
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Ramat Gan, , Israel
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Bergamo, , Italy
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Cisanello (pisa), , Italy
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Milan, , Italy
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Roma, , Italy
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Torino, , Italy
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Bialystok, , Poland
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Kielce, , Poland
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Mysłowice, , Poland
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Racibórz, , Poland
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Wroclaw, , Poland
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Łańcut, , Poland
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Kazan', Tatarstan Republic, 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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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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Stavropol, , Russia
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A Coruña, , Spain
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Alicante, , Spain
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Donostia / San Sebastian, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Seville, , Spain
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Basel, , Switzerland
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Zurich, , Switzerland
Local Institution
Birmingham, WEST Midlands, United Kingdom
Countries
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References
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Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2011-004695-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI452-020
Identifier Type: -
Identifier Source: org_study_id
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