Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)
- Conditions
- Hepatitis C
- Interventions
- Drug: PegIFN/RBVDrug: BI 201335Drug: Placebo
- Registration Number
- NCT01343888
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 656
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PegIFN/RBV PegIFN/RBV PegIFN/RBV for 48 weeks BI 201335 for 12 or 24 weeks PegIFN/RBV BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks BI 201335 for 12 or 24 weeks BI 201335 BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks Placebo and PegIFN/RBV PegIFN/RBV Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48. Placebo and PegIFN/RBV Placebo Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
- Primary Outcome Measures
Name Time Method Sustained Virological Response 12 Weeks Post-treatment (SVR12) 12 weeks post treatment, up to 60 weeks Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \< 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
- Secondary Outcome Measures
Name Time Method Early Treatment Success (ETS) week 4 and week 8 Early treatment success (ETS), defined as a plasma HCV RNA level \<25 IU/mL (detected or undetected) at week 4 and HCV RNA \<25 IU/mL (undetected) at week 8.
Sustained Virological Response 24 Weeks Post-treatment (SVR24) 24 weeks post treatment, up to 72 weeks Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level \< 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES 12 weeks post treatment, up to 60 weeks This will be presented as the number of patients. BL = Baseline
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO 12 weeks post treatment, up to 60 weeks This will be presented as the number of patients. BL = Baseline
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES 12 weeks post treatment, up to 60 weeks This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO 12 weeks post treatment, up to 60 weeks This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES 12 weeks post treatment, up to 60 weeks This will be presented as the number of patients. BL = Baseline
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO 12 weeks post treatment, up to 60 weeks This will be presented as the number of patients. BL = Baseline
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES 12 weeks post treatment, up to 60 weeks This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO 12 weeks post treatment, up to 60 weeks This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Trial Locations
- Locations (98)
1220.30.3201 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1220.30.3203 Boehringer Ingelheim Investigational Site
🇧🇪Liège, Belgium
1220.30.3205 Boehringer Ingelheim Investigational Site
🇧🇪Gent, Belgium
1220.30.3202 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1220.30.3503 Boehringer Ingelheim Investigational Site
🇵🇹Aveiro, Portugal
1220.30.3509 Boehringer Ingelheim Investigational Site
🇵🇹Barreiro, Portugal
1220.30.7002 Boehringer Ingelheim Investigational Site
🇷🇺Chelyabinsk, Russian Federation
1220.30.4108 Boehringer Ingelheim Investigational Site
🇨🇭St. Gallen, Switzerland
1220.30.4303 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1220.30.4302 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1220.30.3507 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1220.30.4003 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1220.30.7006 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1220.30.7007 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1220.30.7001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1220.30.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1220.30.3207 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1220.30.3204 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1220.30.3501 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1220.30.3504 Boehringer Ingelheim Investigational Site
🇵🇹Vila Real, Portugal
1220.30.4002 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1220.30.3505 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1220.30.3502 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
1220.30.4001 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1220.30.4103 Boehringer Ingelheim Investigational Site
🇨🇭La Chaux-de-Fonds, Switzerland
1220.30.4407 Boehringer Ingelheim Investigational Site
🇬🇧Oxford, United Kingdom
1220.30.8106 Boehringer Ingelheim Investigational Site
🇯🇵Chiba, Chiba, Japan
1220.30.4913 Boehringer Ingelheim Investigational Site
🇩🇪Dortmund, Germany
1220.30.3314 Boehringer Ingelheim Investigational Site
🇫🇷Clermont-Ferrand, France
1220.30.3301 Boehringer Ingelheim Investigational Site
🇫🇷Clichy, France
1220.30.3304 Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
1220.30.3303 Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1220.30.3305 Boehringer Ingelheim Investigational Site
🇫🇷Nice Cedex 3, France
1220.30.3315 Boehringer Ingelheim Investigational Site
🇫🇷Rennes Cedex 09, France
1220.30.8119 Boehringer Ingelheim Investigational Site
🇯🇵Omura, Nagasaki, Japan
1220.30.4903 Boehringer Ingelheim Investigational Site
🇩🇪Leipzig, Germany
1220.30.4911 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1220.30.4915 Boehringer Ingelheim Investigational Site
🇩🇪Ulm, Germany
1220.30.8113 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
1220.30.4906 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1220.30.4909 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1220.30.4901 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1220.30.4902 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.30.3313 Boehringer Ingelheim Investigational Site
🇫🇷Toulouse, France
1220.30.8117 Boehringer Ingelheim Investigational Site
🇯🇵Kita-gun, Kagawa, Japan
1220.30.8109 Boehringer Ingelheim Investigational Site
🇯🇵Kofu, Yamanashi, Japan
1220.30.8115 Boehringer Ingelheim Investigational Site
🇯🇵Tanabe, Wakayama, Japan
1220.30.8111 Boehringer Ingelheim Investigational Site
🇯🇵Gifu, Gifu, Japan
1220.30.8114 Boehringer Ingelheim Investigational Site
🇯🇵Nishinomiya, Hyogo, Japan
1220.30.8122 Boehringer Ingelheim Investigational Site
🇯🇵Omuta, Fukuoka, Japan
1220.30.4908 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1220.30.8102 Boehringer Ingelheim Investigational Site
🇯🇵Sendai, Miyagi, Japan
1220.30.8118 Boehringer Ingelheim Investigational Site
🇯🇵Kurume, Fukuoka, Japan
1220.30.8104 Boehringer Ingelheim Investigational Site
🇯🇵Tsuchiura, Ibaraki, Japan
1220.30.3408 Boehringer Ingelheim Investigational Site
🇪🇸Santander, Spain
1220.30.3407 Boehringer Ingelheim Investigational Site
🇪🇸Vigo (Pontevedra), Spain
1220.30.8108 Boehringer Ingelheim Investigational Site
🇯🇵Kamakura, Kanagawa, Japan
1220.30.8112 Boehringer Ingelheim Investigational Site
🇯🇵Izunokuni, Shizuoka, Japan
1220.30.8105 Boehringer Ingelheim Investigational Site
🇯🇵Namegata, Ibaraki, Japan
1220.30.8101 Boehringer Ingelheim Investigational Site
🇯🇵Sapporo, Hokkaido, Japan
1220.30.3506 Boehringer Ingelheim Investigational Site
🇵🇹Coimbra, Portugal
1220.30.3405 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1220.30.3404 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.30.4004 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1220.30.3402 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.30.3406 Boehringer Ingelheim Investigational Site
🇪🇸A Coruña, Spain
1220.30.4404 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.30.3403 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1220.30.4304 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1220.30.3311 Boehringer Ingelheim Investigational Site
🇫🇷Lille, France
1220.30.3316 Boehringer Ingelheim Investigational Site
🇫🇷Pessac Cedex, France
1220.30.3309 Boehringer Ingelheim Investigational Site
🇫🇷Paris Cedex 20, France
1220.30.3312 Boehringer Ingelheim Investigational Site
🇫🇷Saint Laurent du Var, France
1220.30.3302 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1220.30.4904 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.30.4912 Boehringer Ingelheim Investigational Site
🇩🇪Erlangen, Germany
1220.30.4914 Boehringer Ingelheim Investigational Site
🇩🇪Kiel, Germany
1220.30.8107 Boehringer Ingelheim Investigational Site
🇯🇵Itabashi-ku, Tokyo, Japan
1220.30.8116 Boehringer Ingelheim Investigational Site
🇯🇵Kurashiki, Okayama, Japan
1220.30.8110 Boehringer Ingelheim Investigational Site
🇯🇵Matsumoto, Nagano, Japan
1220.30.7005 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1220.30.7004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1220.30.4106 Boehringer Ingelheim Investigational Site
🇨🇭Bern, Switzerland
1220.30.4107 Boehringer Ingelheim Investigational Site
🇨🇭Lugano, Switzerland
1220.30.4101 Boehringer Ingelheim Investigational Site
🇨🇭Zürich, Switzerland
1220.30.4405 Boehringer Ingelheim Investigational Site
🇬🇧Bristol, United Kingdom
1220.30.4409 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.30.4410 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.30.4408 Boehringer Ingelheim Investigational Site
🇬🇧Nottingham, United Kingdom
1220.30.4401 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom
1220.30.4406 Boehringer Ingelheim Investigational Site
🇬🇧Whitechapel, London, United Kingdom
1220.30.4403 Boehringer Ingelheim Investigational Site
🇬🇧Southampton, United Kingdom
1220.30.4917 Boehringer Ingelheim Investigational Site
🇩🇪Aachen, Germany
1220.30.8121 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1220.30.4916 Boehringer Ingelheim Investigational Site
🇩🇪Bonn, Germany
1220.30.4907 Boehringer Ingelheim Investigational Site
🇩🇪Herne, Germany
1220.30.3401 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1220.30.4905 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany