Japanese pegylated interferon (PegIFN) alfa-2b/ribavirin (RBV) combination trial (clinicaltrials.gov) - Aug 22, 2012 - P3, N=131; Recruiting -> Active, not recruiting
Enrollment closed • Hepatitis C Virus
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This study is ongoing, but not recruiting participants.
First Received on April 12, 2012. Last Updated on August 22, 2012 History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party): Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01579474
Purpose
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
Condition
Hepatitis C
Intervention
Drug: BI 201335 high dose
Drug: BI201335 low dose
Phase
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks
Resource links provided by NLM:
MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C
Drug Information available for: Interferon Ribavirin
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Secondary Outcome Measures:
Sustained virological response (SVR), defined as plasma HCV RNV undetectable at 24 week after end of treatment [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]
SVR12, defined as plasma HCV RNA undetectable at 12 weeks after end of treatment [ Time Frame: up to 60 weeks ] [ Designated as safety issue: No ]
Early treatment success (ETS), defined as plasma HCV RNA
ALT normalization, defined as ALT normal at 24 weeks after end of treatment [ Time Frame: uo to 72 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 131
Study Start Date: April 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
IR8
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