A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
- Conditions
- Hepatitis C
- Interventions
- Drug: BI 201335Drug: PegIFN/RBV
- Registration Number
- NCT01330316
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 201335 for 24 weeks BI 201335 BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks BI 201335 for 24 weeks PegIFN/RBV BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
- Primary Outcome Measures
Name Time Method Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL 12 weeks post treatment, up to 60 weeks The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
- Secondary Outcome Measures
Name Time Method Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.
Early Treatment Success (ETS) week 4 and week 8 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.
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment. Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment. 48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.
Occurrence of Serious Adverse Events (SAEs) from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.
Laboratory Test Abnormalities by DAIDS Grades baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.
Changes From Baseline in Laboratory Test Values Over Time [ALT] baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.
In this outcome measure ALT is presented.Changes From Baseline in Laboratory Test Values Over Time [AST] baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.
In this outcome measure AST is presented.Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total] baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.
In this outcome measure Bilirubin total is presented.Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) 24 weeks post treatment, up to 72 weeks Sustained virologic response 24 weeks, defined as a 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 End of Treatment (EoT) Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers. This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.
Occurrence of Adverse Events Leading to Treatment Discontinuation from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.
Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin] baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.
In this outcome measure Haemoglobin is presented.Occurrence of Adverse Events (Overall and by DAIDS Grade) from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days This outcome measure will be presented as the percentage of subjects with any adverse event (AE).
Percentages are calculated using total number of subjects per treatment cohort as the denominator.
The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment.Occurrence of Drug-related AEs as Assessed by the Investigator from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.
Trial Locations
- Locations (87)
1220.48.1007 Boehringer Ingelheim Investigational Site
🇨🇦Victoria, British Columbia, Canada
1220.48.0087 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1220.48.0027 Boehringer Ingelheim Investigational Site
🇺🇸Framingham, Massachusetts, United States
1220.48.0065 Boehringer Ingelheim Investigational Site
🇺🇸Springfield, Massachusetts, United States
1220.48.0066 Boehringer Ingelheim Investigational Site
🇺🇸Neptune, New Jersey, United States
1220.48.0058 Boehringer Ingelheim Investigational Site
🇺🇸Portland, Oregon, United States
1220.48.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1220.48.3201 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1220.48.1016 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1220.48.3204 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1220.48.3203 Boehringer Ingelheim Investigational Site
🇧🇪Liège, Belgium
1220.48.1012 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1220.48.8116 Boehringer Ingelheim Investigational Site
🇯🇵Kurashiki, Okayama, Japan
1220.48.8114 Boehringer Ingelheim Investigational Site
🇯🇵Nishinomiya, Hyogo, Japan
1220.48.8119 Boehringer Ingelheim Investigational Site
🇯🇵Omura, Nagasaki, Japan
1220.48.8121 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1220.48.4002 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1220.48.3503 Boehringer Ingelheim Investigational Site
🇵🇹Aveiro, Portugal
1220.48.3509 Boehringer Ingelheim Investigational Site
🇵🇹Barreiro, Portugal
1220.48.3502 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
1220.48.7001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1220.48.4106 Boehringer Ingelheim Investigational Site
🇨🇭Bern, Switzerland
1220.48.0012 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.48.3303 Boehringer Ingelheim Investigational Site
🇫🇷Marseille Cedex 08, France
1220.48.3316 Boehringer Ingelheim Investigational Site
🇫🇷Pessac Cedex, France
1220.48.0023 Boehringer Ingelheim Investigational Site
🇺🇸Tupelo, Mississippi, United States
1220.48.0004 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1220.48.1006 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1220.48.8205 Boehringer Ingelheim Investigational Site
🇰🇷Pusan, Korea, Republic of
1220.48.0029 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1220.48.0063 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Texas, United States
1220.48.4904 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.48.4908 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1220.48.0071 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1220.48.3305 Boehringer Ingelheim Investigational Site
🇫🇷Nice Cedex 3, France
1220.48.1005 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1220.48.4905 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1220.48.0081 Boehringer Ingelheim Investigational Site
🇺🇸Forth Worth, Texas, United States
1220.48.0039 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Georgia, United States
1220.48.4302 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1220.48.3301 Boehringer Ingelheim Investigational Site
🇫🇷Clichy Cedex, France
1220.48.0017 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1220.48.3311 Boehringer Ingelheim Investigational Site
🇫🇷Lille Cedex, France
1220.48.4902 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.48.8118 Boehringer Ingelheim Investigational Site
🇯🇵Kurume, Fukuoka, Japan
1220.48.3304 Boehringer Ingelheim Investigational Site
🇫🇷Montpellier Cedex 5, France
1220.48.3312 Boehringer Ingelheim Investigational Site
🇫🇷Saint Laurent du Var, France
1220.48.3402 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.48.4401 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom
1220.48.4901 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1220.48.4914 Boehringer Ingelheim Investigational Site
🇩🇪Kiel, Germany
1220.48.4911 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1220.48.8201 Boehringer Ingelheim Investigational Site
🇰🇷Yangsan, Korea, Republic of
1220.48.8106 Boehringer Ingelheim Investigational Site
🇯🇵Chiba, Chiba, Japan
1220.48.8117 Boehringer Ingelheim Investigational Site
🇯🇵Kita-gun, Kagawa, Japan
1220.48.4405 Boehringer Ingelheim Investigational Site
🇬🇧Bristol, United Kingdom
1220.48.8204 Boehringer Ingelheim Investigational Site
🇰🇷Pusan, Korea, Republic of
1220.48.3403 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1220.48.8113 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
1220.48.3410 Boehringer Ingelheim Investigational Site
🇪🇸Majadahonda-Madrid, Spain
1220.48.8207 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1220.48.4403 Boehringer Ingelheim Investigational Site
🇬🇧Southampton, United Kingdom
1220.48.8802 China Medical University Hospital
🇨🇳Taichung, Taiwan
1220.48.3412 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.48.8206 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1220.48.4408 Boehringer Ingelheim Investigational Site
🇬🇧Nottingham, United Kingdom
1220.48.3406 Boehringer Ingelheim Investigational Site
🇪🇸A Coruña, Spain
1220.48.3501 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1220.48.4407 Boehringer Ingelheim Investigational Site
🇬🇧Oxford, United Kingdom
1220.48.4404 Boehringer Ingelheim Investigational Site
🇬🇧Tooting, London, United Kingdom
1220.48.4409 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.48.3411 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.48.1009 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1220.48.0091 Boehringer Ingelheim Investigational Site
🇺🇸North Little Rock, Arkansas, United States
1220.48.0018 Boehringer Ingelheim Investigational Site
🇺🇸Oceanside, California, United States
1220.48.0011 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1220.48.0095 Boehringer Ingelheim Investigational Site
🇺🇸Palm Harbor, Florida, United States
1220.48.0013 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1220.48.1003 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1220.48.4906 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1220.48.4913 Boehringer Ingelheim Investigational Site
🇩🇪Dortmund, Germany
1220.48.7004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1220.48.3404 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.48.3409 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1220.48.0078 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
1220.48.3405 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1220.48.3401 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain