drugset / Trial / NCT01358864

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

NCT01358864

Phase 3 Completed 678 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

Timeline

Start
2011-06
Primary completion
2013-02
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Faldaprevir Small molecule 240 mg
Background Pegylated Interferon-alpha Protein / enzyme biologic
Background Ribavirin Small molecule