Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01728324
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 496
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method SVR12 Rates With Historical Control 12 Week (post-treatment) Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level \<25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.
The number of participants analyzed are actually adjusted number of participant analyzed.Comparisons of SVR12 Rates Across Treatment Arms 12 Week (post-treatment) Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
- Secondary Outcome Measures
Name Time Method SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. 4 weeks (after End Of Treatment) Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level \<25 IU/mL at 4 weeks after EOT.
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT. 4 weeks (after End Of Treatment) Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level \<25 IU/mL at 24 weeks after EOT.
Prognostic Value of SVR12 Predicting SVR24 24 Week (post-treatment) The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
Trial Locations
- Locations (109)
1241.36.00005 Boehringer Ingelheim Investigational Site
🇺🇸Bakersfield, California, United States
1241.36.00002 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Texas, United States
1241.36.61002 Boehringer Ingelheim Investigational Site
🇦🇺Herston, Queensland, Australia
1241.36.00027 Boehringer Ingelheim Investigational Site
🇺🇸Atlanta, Georgia, United States
1241.36.00007 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1241.36.00033 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1241.36.01006 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1241.36.35103 Boehringer Ingelheim Investigational Site
🇵🇹Barreiro, Portugal
1241.36.33008 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1241.36.00009 Boehringer Ingelheim Investigational Site
🇺🇸La Jolla, California, United States
1241.36.00016 Boehringer Ingelheim Investigational Site
🇺🇸North Little Rock, Arkansas, United States
1241.36.00032 Boehringer Ingelheim Investigational Site
🇺🇸Hillsborough, New Jersey, United States
1241.36.39029 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1241.36.33002 Boehringer Ingelheim Investigational Site
🇫🇷Grenoble Cedex 9, France
1241.36.49014 Boehringer Ingelheim Investigational Site
🇩🇪Freiburg, Germany
1241.36.33007 Boehringer Ingelheim Investigational Site
🇫🇷Villejuif Cedex, France
1241.36.49011 Boehringer Ingelheim Investigational Site
🇩🇪Aachen, Germany
1241.36.39023 Boehringer Ingelheim Investigational Site
🇮🇹Bisceglie (bat), Italy
1241.36.34004 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1241.36.44001 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1241.36.64002 Boehringer Ingelheim Investigational Site
🇳🇿Hamilton, New Zealand
1241.36.35104 Boehringer Ingelheim Investigational Site
🇵🇹Coimbra, Portugal
1241.36.35101 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1241.36.34006 Boehringer Ingelheim Investigational Site
🇪🇸Badalona (Barcelona), Spain
1241.36.44007 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom
1241.36.44002 Boehringer Ingelheim Investigational Site
🇬🇧Oxford, United Kingdom
1241.36.44008 Boehringer Ingelheim Investigational Site
🇬🇧Leicester, United Kingdom
1241.36.34001 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet Llobregat (BCN), Spain
1241.36.34003 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1241.36.44005 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1241.36.44010 Boehringer Ingelheim Investigational Site
🇬🇧Newcastle upon Tyne, United Kingdom
1241.36.44004 Boehringer Ingelheim Investigational Site
🇬🇧Plymouth, United Kingdom
1241.36.34005 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1241.36.49008 Boehringer Ingelheim Investigational Site
🇩🇪Erlangen, Germany
1241.36.49009 Boehringer Ingelheim Investigational Site
🇩🇪Esslingen, Germany
1241.36.61007 Boehringer Ingelheim Investigational Site
🇦🇺Randwick, New South Wales, Australia
1241.36.00020 Boehringer Ingelheim Investigational Site
🇺🇸Anaheim, California, United States
1241.36.00013 Boehringer Ingelheim Investigational Site
🇺🇸Oceanside, California, United States
1241.36.00019 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1241.36.00003 Boehringer Ingelheim Investigational Site
🇺🇸Gainesville, Florida, United States
1241.36.00004 Boehringer Ingelheim Investigational Site
🇺🇸Deland, Florida, United States
1241.36.00022 Boehringer Ingelheim Investigational Site
🇺🇸Bradenton, Florida, United States
1241.36.00034 Boehringer Ingelheim Investigational Site
🇺🇸San Francisco, California, United States
1241.36.00006 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
1241.36.00024 Boehringer Ingelheim Investigational Site
🇺🇸Palm Harbor, Florida, United States
1241.36.00010 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
1241.36.00031 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1241.36.00030 Boehringer Ingelheim Investigational Site
🇺🇸Zephyrhills, Florida, United States
1241.36.00018 Boehringer Ingelheim Investigational Site
🇺🇸Tupelo, Mississippi, United States
1241.36.00001 Boehringer Ingelheim Investigational Site
🇺🇸Valparaiso, Indiana, United States
1241.36.00017 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1241.36.00043 Boehringer Ingelheim Investigational Site
🇺🇸Kansas City, Missouri, United States
1241.36.00035 Boehringer Ingelheim Investigational Site
🇺🇸Springfield, Illinois, United States
1241.36.00008 Boehringer Ingelheim Investigational Site
🇺🇸Murray, Utah, United States
1241.36.00039 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1241.36.00026 Boehringer Ingelheim Investigational Site
🇺🇸Charlottesville, Virginia, United States
1241.36.00015 Boehringer Ingelheim Investigational Site
🇺🇸Norfolk, Virginia, United States
1241.36.00029 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
1241.36.00044 Boehringer Ingelheim Investigational Site
🇺🇸Newport News, Virginia, United States
1241.36.61005 Boehringer Ingelheim Investigational Site
🇦🇺Camperdown, New South Wales, Australia
1241.36.61010 Boehringer Ingelheim Investigational Site
🇦🇺Kogarah, New South Wales, Australia
1241.36.61009 Boehringer Ingelheim Investigational Site
🇦🇺New Lambton, New South Wales, Australia
1241.36.61004 Boehringer Ingelheim Investigational Site
🇦🇺Clayton, Victoria, Australia
1241.36.61001 Boehringer Ingelheim Investigational Site
🇦🇺Darlinghurst, Victoria, Australia
1241.36.61008 Boehringer Ingelheim Investigational Site
🇦🇺Heidelberg, Victoria, Australia
1241.36.61006 Boehringer Ingelheim Investigational Site
🇦🇺Melbourne, Victoria, Australia
1241.36.32006 Boehringer Ingelheim Investigational Site
🇧🇪Antwerpen, Belgium
1241.36.32005 Boehringer Ingelheim Investigational Site
🇧🇪Gent, Belgium
1241.36.32001 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1241.36.32002 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1241.36.01005 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1241.36.32007 Boehringer Ingelheim Investigational Site
🇧🇪Roeselare, Belgium
1241.36.01002 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1241.36.01003 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1241.36.01001 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada
1241.36.01004 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1241.36.33004 Boehringer Ingelheim Investigational Site
🇫🇷Creteil, France
1241.36.01007 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1241.36.33001 Boehringer Ingelheim Investigational Site
🇫🇷Clichy Cedex, France
1241.36.33003 Boehringer Ingelheim Investigational Site
🇫🇷Paris Cedex 20, France
1241.36.33006 Boehringer Ingelheim Investigational Site
🇫🇷Saint Laurent du Var Cedex, France
1241.36.33005 Boehringer Ingelheim Investigational Site
🇫🇷Toulouse, France
1241.36.49001 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1241.36.49012 Boehringer Ingelheim Investigational Site
🇩🇪Dortmund, Germany
1241.36.49004 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1241.36.64001 Boehringer Ingelheim Investigational Site
🇳🇿Auckland NZ, New Zealand
1241.36.49007 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1241.36.49013 Boehringer Ingelheim Investigational Site
🇩🇪Tübingen, Germany
1241.36.30004 Boehringer Ingelheim Investigational Site
🇬🇷Rhodes, Greece
1241.36.49002 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1241.36.30003 Boehringer Ingelheim Investigational Site
🇬🇷Patras, Greece
1241.36.30001 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1241.36.30002 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1241.36.39025 Boehringer Ingelheim Investigational Site
🇮🇹Antella (fi), Italy
1241.36.39022 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1241.36.39028 Boehringer Ingelheim Investigational Site
🇮🇹Pescara, Italy
1241.36.39021 Boehringer Ingelheim Investigational Site
🇮🇹Bologna, Italy
1241.36.39026 Boehringer Ingelheim Investigational Site
🇮🇹Pavia, Italy
1241.36.39020 Boehringer Ingelheim Investigational Site
🇮🇹Palermo, Italy
1241.36.39024 Boehringer Ingelheim Investigational Site
🇮🇹San Giovanni Rotondo (fg), Italy
1241.36.34002 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1241.36.44006 Boehringer Ingelheim Investigational Site
🇬🇧Edinburgh, United Kingdom
1241.36.34008 Boehringer Ingelheim Investigational Site
🇪🇸Malaga, Spain
1241.36.44013 Boehringer Ingelheim Investigational Site
🇬🇧Leeds, United Kingdom
1241.36.44003 Boehringer Ingelheim Investigational Site
🇬🇧Birmingham, United Kingdom
1241.36.44011 Boehringer Ingelheim Investigational Site
🇬🇧Hull, United Kingdom
1241.36.34007 Boehringer Ingelheim Investigational Site
🇪🇸Vigo (Pontevedra), Spain
1241.36.32004 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1241.36.32003 Boehringer Ingelheim Investigational Site
🇧🇪Liège, Belgium