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 2)
- Registration Number
- NCT01297270
- 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
- 658
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI201335 for 12 weeks PegIFN/RBV BI 201335 QD doing in combination with PEFG IFN/RBV BI201335 for 12 weeks BI201335 BI 201335 QD doing in combination with PEFG IFN/RBV BI 201335 for 24 weeks PegIFN/RBV BI 201 335 QD dosing in combination with IFN/RBV BI 201335 for 24 weeks BI201335 BI 201 335 QD dosing in combination with IFN/RBV PegIFN/RBV PegIFN/RBV 48 weeks Placebo Placebo -
- Primary Outcome Measures
Name Time Method Sustained Virologic Response 12 Weeks Post Treatment (SVR12) 12 weeks post treatment, up to 60 weeks Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) 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 ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES 12 weeks post treatment, up to 60 weeks The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO 12 weeks post treatment, up to 60 weeks The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES 12 weeks post treatment, up to 60 weeks The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-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 12 weeks post-treatment when patients do not 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 (detected or undetected) at week 4 and HCV RNA \<25 IU/mL (undetected) at week 8.
Sustained Virologic Response 24 Weeks Post-treatment (SVR24) 24 weeks post treatment, up to 72 weeks Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level \< 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Hepatitis C virus Ribonucleic acid (HCV RNA)AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES 12 weeks post treatment, up to 60 weeks The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO 12 weeks post treatment, up to 60 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 (EOT) When SVR12=YES 12 weeks post treatment, up to 60 weeks The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
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 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
Trial Locations
- Locations (106)
1220.47.0004 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1220.47.0045 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1220.47.0050 Boehringer Ingelheim Investigational Site
🇺🇸Dothan, Alabama, United States
1220.47.0061 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
1220.47.0091 Boehringer Ingelheim Investigational Site
🇺🇸North Little Rock, Arkansas, United States
1220.47.0008 Boehringer Ingelheim Investigational Site
🇺🇸Bakersfield, California, United States
1220.47.0019 Boehringer Ingelheim Investigational Site
🇺🇸Chula Vista, California, United States
1220.47.0010 Boehringer Ingelheim Investigational Site
🇺🇸Coronado, California, United States
1220.47.0033 Boehringer Ingelheim Investigational Site
🇺🇸La Jolla, California, United States
1220.47.0035 Boehringer Ingelheim Investigational Site
🇺🇸La Mesa, California, United States
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