Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01358864
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 678
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI201335 12 weeks Ribavirin (RBV) patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks BI201335 24 weeks Ribavirin (RBV) patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks BI201335 12 weeks BI 201335 patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks BI201335 12 weeks Pegylated Interferon-alpha (IFN) patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks Placebo/PegIFN/RBV Placebo patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks BI201335 24 weeks BI 201335 patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks Placebo/PegIFN/RBV Pegylated Interferon-alpha (IFN) patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks Placebo/PegIFN/RBV Ribavirin (RBV) patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks BI201335 24 weeks Pegylated Interferon-alpha (IFN) patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
- Primary Outcome Measures
Name Time Method Sustained Virological Response 12 Weeks Post Treatment (SVR12) 12 weeks post treatment, up to 60 weeks Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
- Secondary Outcome Measures
Name Time Method Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) 24 weeks post treatment, up to 72 weeks Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO 12 weeks post treatment, up to 60 weeks The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO End of treatment, up to 48 weeks The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES End of treatment, up to 48 weeks The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES 12 weeks post treatment, up to 60 weeks The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Early Treatment Success (ETS) Week 4 and Week 8 Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level \<25 IU/mL (undetected or detected) at Week 4 and \<25 IU/mL (undetected) at Week 8.
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES 12 weeks post treatment, up to 60 weeks The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO End of treatment, up to 48 weeks The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES End of treatment, up to 48 weeks The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO 12 weeks post treatment, up to 60 weeks The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Trial Locations
- Locations (116)
1220.7.0085 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1220.7.0087 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1220.7.1006 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1220.7.8105 Boehringer Ingelheim Investigational Site
🇯🇵Namegata, Ibaraki, Japan
1220.7.0101 Boehringer Ingelheim Investigational Site
🇺🇸New Orleans, Louisiana, United States
1220.7.4303 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1220.7.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1220.7.3201 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1220.7.1007 Boehringer Ingelheim Investigational Site
🇨🇦Victoria, British Columbia, Canada
1220.7.3206 Boehringer Ingelheim Investigational Site
🇧🇪Jette, Belgium
1220.7.3203 Boehringer Ingelheim Investigational Site
🇧🇪Liège, Belgium
1220.7.1014 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1220.7.1012 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1220.7.1011 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1220.7.8107 Boehringer Ingelheim Investigational Site
🇯🇵Itabashi-ku, Tokyo, Japan
1220.7.8108 Boehringer Ingelheim Investigational Site
🇯🇵Kamakura, Kanagawa, Japan
1220.7.8117 Boehringer Ingelheim Investigational Site
🇯🇵Kita-gun, Kagawa, Japan
1220.7.8109 Boehringer Ingelheim Investigational Site
🇯🇵Kofu, Yamanashi, Japan
1220.7.8116 Boehringer Ingelheim Investigational Site
🇯🇵Kurashiki, Okayama, Japan
1220.7.8118 Boehringer Ingelheim Investigational Site
🇯🇵Kurume, Fukuoka, Japan
1220.7.8110 Boehringer Ingelheim Investigational Site
🇯🇵Matsumoto, Nagano, Japan
1220.7.8124 Boehringer Ingelheim Investigational Site
🇯🇵Matsuyama, Ehime, Japan
1220.7.8113 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
1220.7.8114 Boehringer Ingelheim Investigational Site
🇯🇵Nishinomiya, Hyogo, Japan
1220.7.8125 Boehringer Ingelheim Investigational Site
🇯🇵Ogaki, Gifu, Japan
1220.7.8119 Boehringer Ingelheim Investigational Site
🇯🇵Omura, Nagasaki, Japan
1220.7.8122 Boehringer Ingelheim Investigational Site
🇯🇵Omuta, Fukuoka, Japan
1220.7.8121 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1220.7.8101 Boehringer Ingelheim Investigational Site
🇯🇵Sapporo, Hokkaido, Japan
1220.7.8102 Boehringer Ingelheim Investigational Site
🇯🇵Sendai, Miyagi, Japan
1220.7.8115 Boehringer Ingelheim Investigational Site
🇯🇵Tanabe, Wakayama, Japan
1220.7.8126 Boehringer Ingelheim Investigational Site
🇯🇵Tsu, Mie, Japan
1220.7.8104 Boehringer Ingelheim Investigational Site
🇯🇵Tsuchiura, Ibaraki, Japan
1220.7.3503 Boehringer Ingelheim Investigational Site
🇵🇹Aveiro, Portugal
1220.7.3509 Boehringer Ingelheim Investigational Site
🇵🇹Barreiro, Portugal
1220.7.3501 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1220.7.3505 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1220.7.3502 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
1220.7.0034 Boehringer Ingelheim Investigational Site
🇵🇷San Juan, Puerto Rico
1220.7.4108 Boehringer Ingelheim Investigational Site
🇨🇭St. Gallen, Switzerland
1220.7.4101 Boehringer Ingelheim Investigational Site
🇨🇭Zürich, Switzerland
1220.7.0009 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1220.7.0071 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1220.7.0029 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1220.7.1004 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada
1220.7.1010 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1220.7.3304 Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
1220.7.3305 Boehringer Ingelheim Investigational Site
🇫🇷Nice Cedex 3, France
1220.7.3204 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1220.7.3311 Boehringer Ingelheim Investigational Site
🇫🇷Lille, France
1220.7.3303 Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1220.7.3316 Boehringer Ingelheim Investigational Site
🇫🇷Pessac Cedex, France
1220.7.3315 Boehringer Ingelheim Investigational Site
🇫🇷Rennes Cedex 09, France
1220.7.4913 Boehringer Ingelheim Investigational Site
🇩🇪Dortmund, Germany
1220.7.4907 Boehringer Ingelheim Investigational Site
🇩🇪Herne, Germany
1220.7.4905 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1220.7.3207 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1220.7.0016 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1220.7.3202 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1220.7.8111 Boehringer Ingelheim Investigational Site
🇯🇵Gifu, Gifu, Japan
1220.7.3310 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1220.7.4904 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.7.4903 Boehringer Ingelheim Investigational Site
🇩🇪Leipzig, Germany
1220.7.3317 Boehringer Ingelheim Investigational Site
🇫🇷Reims, France
1220.7.4302 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1220.7.3205 Boehringer Ingelheim Investigational Site
🇧🇪Gent, Belgium
1220.7.4911 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1220.7.3302 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1220.7.4908 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1220.7.8112 Boehringer Ingelheim Investigational Site
🇯🇵Izunokuni, Shizuoka, Japan
1220.7.3301 Boehringer Ingelheim Investigational Site
🇫🇷Clichy, France
1220.7.3318 Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1220.7.3402 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.7.4918 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1220.7.3308 Boehringer Ingelheim Investigational Site
🇫🇷Vandoeuvre Cedex, France
1220.7.4408 Boehringer Ingelheim Investigational Site
🇬🇧Nottingham, United Kingdom
1220.7.3407 Boehringer Ingelheim Investigational Site
🇪🇸Vigo (Pontevedra), Spain
1220.7.3405 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1220.7.4901 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1220.7.8106 Boehringer Ingelheim Investigational Site
🇯🇵Chiba, Chiba, Japan
1220.7.8123 Boehringer Ingelheim Investigational Site
🇯🇵Toyama,Toyama, Japan
1220.7.3506 Boehringer Ingelheim Investigational Site
🇵🇹Coimbra, Portugal
1220.7.4906 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1220.7.3401 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1220.7.3404 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.7.4103 Boehringer Ingelheim Investigational Site
🇨🇭La Chaux-de-Fonds, Switzerland
1220.7.4107 Boehringer Ingelheim Investigational Site
🇨🇭Lugano, Switzerland
1220.7.4407 Boehringer Ingelheim Investigational Site
🇬🇧Oxford, United Kingdom
1220.7.3412 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.7.4401 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom
1220.7.4403 Boehringer Ingelheim Investigational Site
🇬🇧Southampton, United Kingdom
1220.7.3409 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1220.7.3406 Boehringer Ingelheim Investigational Site
🇪🇸A Coruña, Spain
1220.7.3411 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.7.0063 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Texas, United States
1220.7.0091 Boehringer Ingelheim Investigational Site
🇺🇸North Little Rock, Arkansas, United States
1220.7.0082 Boehringer Ingelheim Investigational Site
🇺🇸Englewood, Colorado, United States
1220.7.0095 Boehringer Ingelheim Investigational Site
🇺🇸Palm Harbor, Florida, United States
1220.7.0013 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1220.7.0039 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Georgia, United States
1220.7.0062 Boehringer Ingelheim Investigational Site
🇺🇸Vaiparaiso, Indiana, United States
1220.7.0027 Boehringer Ingelheim Investigational Site
🇺🇸Framingham, Massachusetts, United States
1220.7.0012 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.7.0077 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
1220.7.4902 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.7.4106 Boehringer Ingelheim Investigational Site
🇨🇭Bern, Switzerland
1220.7.3403 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1220.7.3408 Boehringer Ingelheim Investigational Site
🇪🇸Santander, Spain
1220.7.4405 Boehringer Ingelheim Investigational Site
🇬🇧Bristol, United Kingdom
1220.7.4409 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.7.4404 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.7.4410 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.7.3410 Boehringer Ingelheim Investigational Site
🇪🇸Majadahonda-Madrid, Spain
1220.7.0058 Boehringer Ingelheim Investigational Site
🇺🇸Portland, Oregon, United States
1220.7.1003 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1220.7.1016 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada