Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01858961
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 ribavirin BI 201335 in combination with BI 207127 and ribavirin for 24 weeks Group 1 BI 201335 BI 201335 in combination with BI 207127 and ribavirin for 24 weeks Group 2 ribavirin Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks Group 2 Pegylated Interferon Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks Group 1 BI 207127 BI 201335 in combination with BI 207127 and ribavirin for 24 weeks Group 2 Telaprevir Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks
- Primary Outcome Measures
Name Time Method Sustained Virologic Response at Week 12 after end of treatment (SVR12) at week 12 post treatment
- Secondary Outcome Measures
Name Time Method SVR4: Plasma HCV RNA level <25 IU/mL1 at 4 weeks after end of treatment at week 4 post treatment SVR24: Plasma HCV RNA level <25 IU/mL1 at 24 weeks after end of treatment at week 4 post treatment Virological Response at Week 4 -Plasma HCV RNA level undetectable at Week 4 -Plasma HCV RNA level <25 IU/mL at Week 4 at week 4 post treatment Lack of on-treatment viral response up to week 48 Relapse up to 48 weeks post treatment Serious Adverse Events up to week 48 post treatment Laboratory test abnormalities by DAIDS grades up to week 48 post treatment Rate of red blood cell transfusion up to week 48 post treatment Time to discontinuation of trial medication up to week 48 Plasma HCV level undetectable at Week 12 at week 12 Time to achieving HCV RNA undetectable up to week 48 Adverse events up to week 48 post treatment Adverse events leading to discontinuation up to week 48 Liver disease progression, fibroscan and FibroSURE up to week 48 post treatment Rate of ESA use up to week 48 post treatment Change in laboratory test values over time up to week 48 post treatment Patients requiring hospitalisation due to AEs related to study drugs up to week 48 post treatment Virological breakthrough up to week 48 ETR: Plasma HCV RNA level undetected at the end of treatment week 24 or 48
Trial Locations
- Locations (12)
1241.37.61002 Boehringer Ingelheim Investigational Site
🇦🇺Westmead, New South Wales, Australia
1241.37.61001 Boehringer Ingelheim Investigational Site
🇦🇺Adelaide, South Australia, Australia
1241.37.61003 Boehringer Ingelheim Investigational Site
🇦🇺Fitzroy, Victoria, Australia
1241.37.34010 Boehringer Ingelheim Investigational Site
🇪🇸Alzira, Spain
1241.37.34005 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1241.37.34002 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet Llobregat (BCN), Spain
1241.37.34001 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1241.37.34003 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1241.37.34004 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1241.37.34006 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
Scroll for more (2 remaining)1241.37.61002 Boehringer Ingelheim Investigational Site🇦🇺Westmead, New South Wales, Australia