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)
- Conditions
- Hepatitis C
- Interventions
- Drug: BI201335Drug: PlaceboDrug: PegIFN/RBV
- 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)
1220.47.0057 Boehringer Ingelheim Investigational Site
🇺🇸Bradenton, Florida, United States
1220.47.0078 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
1220.47.0086 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
1220.47.0054 Boehringer Ingelheim Investigational Site
🇺🇸Hialeah, Florida, United States
1220.47.0095 Boehringer Ingelheim Investigational Site
🇺🇸Palm Harbor, Florida, United States
1220.47.0085 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1220.47.0066 Boehringer Ingelheim Investigational Site
🇺🇸Neptune, New Jersey, United States
1220.47.0087 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1220.47.0064 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
1220.47.0079 Boehringer Ingelheim Investigational Site
🇺🇸Lutherville, Maryland, United States
1220.47.0067 Boehringer Ingelheim Investigational Site
🇺🇸Chevy Chase, Maryland, United States
1220.47.0030 Boehringer Ingelheim Investigational Site
🇺🇸Germantown, Tennessee, United States
1220.47.0027 Boehringer Ingelheim Investigational Site
🇺🇸Framingham, Massachusetts, United States
1220.47.0065 Boehringer Ingelheim Investigational Site
🇺🇸Springfield, Massachusetts, United States
1220.47.0023 Boehringer Ingelheim Investigational Site
🇺🇸Tulepo, Mississippi, United States
1220.47.1015 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1220.47.0072 Boehringer Ingelheim Investigational Site
🇺🇸Jackson, Tennessee, United States
1220.47.1007 Boehringer Ingelheim Investigational Site
🇨🇦Victoria, British Columbia, Canada
1220.47.1013 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1220.47.8204 Boehringer Ingelheim Investigational Site
🇰🇷Pusan, Korea, Republic of
1220.47.1001 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1220.47.1003 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1220.47.1006 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1220.47.8804 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1220.47.1016 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1220.47.1004 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada
1220.47.1010 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1220.47.8205 Boehringer Ingelheim Investigational Site
🇰🇷Pusan, Korea, Republic of
1220.47.8203 Boehringer Ingelheim Investigational Site
🇰🇷Seongnam, Korea, Republic of
1220.47.8207 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1220.47.8802 Boehringer Ingelheim Investigational Site
🇨🇳Taichung, Taiwan
1220.47.8801 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1220.47.8805 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1220.47.0022 Boehringer Ingelheim Investigational Site
🇺🇸Atlanta, Georgia, United States
1220.47.0068 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1220.47.0046 Boehringer Ingelheim Investigational Site
🇺🇸Las Vegas, Nevada, United States
1220.47.0050 Boehringer Ingelheim Investigational Site
🇺🇸Dothan, Alabama, United States
1220.47.0011 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1220.47.0014 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1220.47.0055 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1220.47.0062 Boehringer Ingelheim Investigational Site
🇺🇸Vaiparaiso, Indiana, 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
1220.47.0013 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1220.47.0019 Boehringer Ingelheim Investigational Site
🇺🇸Chula Vista, California, United States
1220.47.0018 Boehringer Ingelheim Investigational Site
🇺🇸Oceanside, California, United States
1220.47.0100 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1220.47.0091 Boehringer Ingelheim Investigational Site
🇺🇸North Little Rock, Arkansas, United States
1220.47.0017 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1220.47.0003 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.47.0098 Boehringer Ingelheim Investigational Site
🇺🇸Tulsa, Oklahoma, United States
1220.47.0071 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1220.47.0009 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1220.47.0092 Boehringer Ingelheim Investigational Site
🇺🇸Seattle, Washington, United States
1220.47.0006 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.47.0090 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.47.0056 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1220.47.0038 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.47.0043 Boehringer Ingelheim Investigational Site
🇺🇸Falls Church, Virginia, United States
1220.47.0063 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Texas, United States
1220.47.1002 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1220.47.0081 Boehringer Ingelheim Investigational Site
🇺🇸Forth Worth, Texas, United States
1220.47.8803 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1220.47.1005 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1220.47.1014 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1220.47.1009 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1220.47.0082 Boehringer Ingelheim Investigational Site
🇺🇸Englewood, Colorado, United States
1220.47.0024 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1220.47.0037 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1220.47.0031 Boehringer Ingelheim Investigational Site
🇺🇸San Francisco, California, United States
1220.47.0032 Boehringer Ingelheim Investigational Site
🇺🇸Nashville, Tennessee, United States
1220.47.0004 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1220.47.0045 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1220.47.0061 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
1220.47.0028 Boehringer Ingelheim Investigational Site
🇺🇸Portland, Oregon, United States
1220.47.0016 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1220.47.0041 Boehringer Ingelheim Investigational Site
🇺🇸Nashville, Tennessee, United States
1220.47.0058 Boehringer Ingelheim Investigational Site
🇺🇸Portland, Oregon, United States
1220.47.0083 Boehringer Ingelheim Investigational Site
🇺🇸Brooklyn, New York, United States
1220.47.8206 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1220.47.8202 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1220.47.8201 Boehringer Ingelheim Investigational Site
🇰🇷Yangsan, Korea, Republic of
1220.47.0034 Boehringer Ingelheim Investigational Site
🇵🇷San Juan, Puerto Rico
1220.47.0035 Boehringer Ingelheim Investigational Site
🇺🇸La Mesa, California, United States
1220.47.0008 Boehringer Ingelheim Investigational Site
🇺🇸Bakersfield, California, United States
1220.47.0039 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Georgia, United States
1220.47.0088 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1220.47.0052 Boehringer Ingelheim Investigational Site
🇺🇸Decatur, Georgia, United States
1220.47.0069 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
1220.47.0053 Boehringer Ingelheim Investigational Site
🇺🇸Charlotte, North Carolina, United States
1220.47.0060 Boehringer Ingelheim Investigational Site
🇺🇸Fort Worth, Texas, United States
1220.47.0042 Boehringer Ingelheim Investigational Site
🇺🇸Annandale, Virginia, United States
1220.47.1011 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1220.47.0015 Boehringer Ingelheim Investigational Site
🇺🇸Burlington, Vermont, United States
1220.47.0049 Boehringer Ingelheim Investigational Site
🇺🇸New Haven, Connecticut, United States
1220.47.0044 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
1220.47.0099 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
1220.47.0074 Boehringer Ingelheim Investigational Site
🇺🇸Tampa, Florida, United States
1220.47.0101 Boehringer Ingelheim Investigational Site
🇺🇸New Orleans, Louisiana, United States
1220.47.0097 Boehringer Ingelheim Investigational Site
🇺🇸Bronx, New York, United States
1220.47.0021 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
1220.47.0029 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1220.47.0026 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
1220.47.0073 Boehringer Ingelheim Investigational Site
🇺🇸Milwaukee, Wisconsin, United States
1220.47.1012 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1220.47.0059 Boehringer Ingelheim Investigational Site
🇺🇸Poway, California, United States