Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
- Conditions
- Hepatitis C
- Interventions
- Drug: BI 201335 high doseDrug: BI 201335 low dose
- Registration Number
- NCT01579474
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2. BI 201335 high dose plus PegIFN/RBV BI 201335 high dose high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients 3. BI 201335 high dose plus PegIFN/RBV BI 201335 high dose high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients 4. BI 201335 high dose plus PegIFN/RBV BI 201335 high dose high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients 1. BI 201335 low dose plus PegIFN/RBV BI 201335 low dose low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
- Primary Outcome Measures
Name Time Method Number of Patients With Investigator Defined Drug-related Adverse Events Up to 52 weeks Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
- Secondary Outcome Measures
Name Time Method Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES 12 weeks after the EOT (up to Week 36 or 60) 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=YES EOT (up to Week 24 or 48) This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72) 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 after the EOT (up to Week 36 or 60) This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60) Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES EOT (up to Week 24 or 48) 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 EOT (up to Week 24 or 48) 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 Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO 12 weeks after the EOT (up to Week 36 or 60) 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=NO 12 weeks after the EOT (up to Week 36 or 60) 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 EOT (up to Week 24 or 48) This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 up to 8 weeks Plasma HCV RNA level \<25 IU/mL (detected or undetected) at Week 4 and HCV RNA \<25 IU/mL (undetected) at Week 8
Trial Locations
- Locations (24)
1220.54.08115 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1220.54.08101 Boehringer Ingelheim Investigational Site
🇯🇵Sapporo, Hokkaido, Japan
1220.54.08104 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku, Chiba, Japan
1220.54.08102 Boehringer Ingelheim Investigational Site
🇯🇵Sendai, Miyagi, Japan
1220.54.08119 Boehringer Ingelheim Investigational Site
🇯🇵Tanabe, Wakayama, Japan
1220.54.08110 Boehringer Ingelheim Investigational Site
🇯🇵Gifu, Gifu, Japan
1220.54.08118 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku, Kobe, Hyogo, Japan
1220.54.08108 Boehringer Ingelheim Investigational Site
🇯🇵Fukui, Fukui, Japan
1220.54.08105 Boehringer Ingelheim Investigational Site
🇯🇵Itabashi-ku, Tokyo, Japan
1220.54.08112 Boehringer Ingelheim Investigational Site
🇯🇵Izunokuni, Shizuoka, Japan
1220.54.08120 Boehringer Ingelheim Investigational Site
🇯🇵Kita-gun, Kagawa, Japan
1220.54.08107 Boehringer Ingelheim Investigational Site
🇯🇵Kanazawa, Ishikawa, Japan
1220.54.08109 Boehringer Ingelheim Investigational Site
🇯🇵Kofu, Yamanashi, Japan
1220.54.08123 Boehringer Ingelheim Investigational Site
🇯🇵Kurume, Fukuoka, Japan
1220.54.08121 Boehringer Ingelheim Investigational Site
🇯🇵Mtsuyama, Ehime, Japan
1220.54.08113 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
1220.54.08117 Boehringer Ingelheim Investigational Site
🇯🇵Nishinomiya, Hyogo, Japan
1220.54.08124 Boehringer Ingelheim Investigational Site
🇯🇵Oo mura, Nagasaki,, Japan
1220.54.08111 Boehringer Ingelheim Investigational Site
🇯🇵Ogaki, Gifu, Japan
1220.54.08106 Boehringer Ingelheim Investigational Site
🇯🇵Toyama,Toyama, Japan
1220.54.08116 Boehringer Ingelheim Investigational Site
🇯🇵Osakasayama, Osaka, Japan
1220.54.08114 Boehringer Ingelheim Investigational Site
🇯🇵Tsu, Mie, Japan
1220.54.08122 Boehringer Ingelheim Investigational Site
🇯🇵Yahatanishi-ku, Kitakyusyu, Fukuoka, Japan
1220.54.08125 Boehringer Ingelheim Investigational Site
🇯🇵Yamagata, Yamagata, Japan