Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01132313
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.
The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.
A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.
This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.
Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 488
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 7 BI 201335 28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2 8 BI 207127 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3 8 BI 201335 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3 9 BI 207127 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3 9 BI 201335 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3 2 BI 201335 4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1 2 BI 207127 4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1 1 BI 207127 4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1 1 BI 201335 4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1 3 BI 207127 16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 3 BI 201335 16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 4 BI 207127 28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 4 BI 201335 28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 6 BI 207217 28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2 7 BI 207127 28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2 10 BI 201335 24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3 11 BI 207127 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4 11 BI 201335 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4 12 BI 207127 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4 6 BI 201335 28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2 12 BI 201335 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4 5 BI 201335 40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 5 BI 207127 40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 10 BI 207127 24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3 2 Ribavirin 4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1 1 Ribavirin 4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1 3 Ribavirin 16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 6 Ribavirin 28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2 4 Ribavirin 28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 5 Ribavirin 40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 8 Ribavirin 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3 9 Ribavirin 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3 10 Ribavirin 24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3 11 Ribavirin 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4 12 Ribavirin 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
- Primary Outcome Measures
Name Time Method Part 1: Rapid Virological Response (RVR) 4 weeks Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) \<25IU/mL at Week 4 of treatment
Part 2: Sustained Virological Response (SVR) From drug administration until 12 weeks after end of treatment, up to 52 weeks Part 2: Sustained virological response (SVR), defined as HCV RNA \<25 IU/mL and undetectable at 12 weeks after end of treatment
Part 3 and 4: Sustained Virological Response (SVR) From drug administration until 12 weeks after end of treatment, up to 36 weeks Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA \<25IU/mL and undetectable at 12 weeks after end of treatment
- Secondary Outcome Measures
Name Time Method Part 1: Time to Virological Response From drug administration until end of drug administration, up to 4 weeks Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level \<25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Part 2: Time to Virological Response From drug administration until end of drug administration, up to 40 weeks Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level \<25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4 4 weeks Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment 4 weeks and 24 weeks after the end of treatment, up to 64 weeks Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment Week 4 and 12 Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level \<25 IU/mL at week 4 and 12 of treatment
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment up to 28 weeks Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
Trial Locations
- Locations (53)
1241.21.0004 Boehringer Ingelheim Investigational Site
🇺🇸San Francisco, California, United States
1241.21.0012 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Texas, United States
1241.21.0003 Boehringer Ingelheim Investigational Site
🇺🇸La Jolla, California, United States
1241.21.0007 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1241.21.0011 Boehringer Ingelheim Investigational Site
🇺🇸Palm Harbor, Florida, United States
1241.21.61002 Boehringer Ingelheim Investigational Site
🇦🇺Heidelberg, Victoria, Australia
1241.21.0010 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1241.21.0006 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1241.21.49003 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1241.21.34002 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1241.21.34005 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1241.21.49004 Boehringer Ingelheim Investigational Site
🇩🇪Leipzig, Germany
1241.21.49005 Boehringer Ingelheim Investigational Site
🇩🇪Esslingen, Germany
1241.21.0017 Boehringer Ingelheim Investigational Site
🇺🇸Seattle, Washington, United States
1241.21.61001 Boehringer Ingelheim Investigational Site
🇦🇺Melbourne, Victoria, Australia
1241.21.33005 Boehringer Ingelheim Investigational Site
🇫🇷Clichy, France
1241.21.34001 Boehringer Ingelheim Investigational Site
🇪🇸Majadahonda-Madrid, Spain
1241.21.64001 Boehringer Ingelheim Investigational Site
🇳🇿Auckland NZ, New Zealand
1241.21.33003 Boehringer Ingelheim Investigational Site
🇫🇷Lyon, France
1241.21.49008 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1241.21.49002 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1241.21.34003 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1241.21.33001 Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1241.21.49009 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1241.21.33007 Boehringer Ingelheim Investigational Site
🇫🇷Grenoble cédex 9, France
1241.21.33008 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1241.21.43001 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1241.21.35101 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1241.21.43003 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1241.21.40001 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1241.21.35104 Boehringer Ingelheim Investigational Site
🇵🇹Coimbra, Portugal
1241.21.35105 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1241.21.40002 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1241.21.40003 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1241.21.41003 Boehringer Ingelheim Investigational Site
🇨ðŸ‡Basel, Switzerland
1241.21.41002 Boehringer Ingelheim Investigational Site
🇨ðŸ‡Zürich, Switzerland
1241.21.0005 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1241.21.43002 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1241.21.33002 Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
1241.21.33006 Boehringer Ingelheim Investigational Site
🇫🇷Vandoeuvre Cedex, France
1241.21.33004 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1241.21.49006 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1241.21.35103 Boehringer Ingelheim Investigational Site
🇵🇹Aveiro, Portugal
1241.21.35102 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
1241.21.41001 Boehringer Ingelheim Investigational Site
🇨ðŸ‡St. Gallen, Switzerland
1241.21.41006 Boehringer Ingelheim Investigational Site
🇨ðŸ‡Bern, Switzerland
1241.21.34004 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1241.21.0013 Boehringer Ingelheim Investigational Site
🇺🇸Valparaiso, Indiana, United States
1241.21.49001 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1241.21.0008 Boehringer Ingelheim Investigational Site
🇺🇸Springfield, Massachusetts, United States
1241.21.0019 Boehringer Ingelheim Investigational Site
🇺🇸Fayetteville, North Carolina, United States
1241.21.49007 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1241.21.34006 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain