A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

Phase 3

Completed

Conditions: Hepatitis C

Interventions: Drug: BI 201335
Drug: 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24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.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

Inclusion Criteria

Not provided

Exclusion Criteria

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): 1220.48.0004 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
1220.48.0091 Boehringer Ingelheim Investigational Site
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North Little Rock, Arkansas, United States
1220.48.0011 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
1220.48.0018 Boehringer Ingelheim Investigational Site
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Oceanside, California, United States
1220.48.0078 Boehringer Ingelheim Investigational Site
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Fort Lauderdale, Florida, United States
1220.48.0095 Boehringer Ingelheim Investigational Site
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Palm Harbor, Florida, United States
1220.48.0039 Boehringer Ingelheim Investigational Site
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Columbus, Georgia, United States
1220.48.0013 Boehringer Ingelheim Investigational Site
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Chicago, Illinois, United States
1220.48.0087 Boehringer Ingelheim Investigational Site
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Baton Rouge, Louisiana, United States
1220.48.0027 Boehringer Ingelheim Investigational Site
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Framingham, Massachusetts, United States
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1220.48.0004 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States