NCT01608737

A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection

A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 for 12 or 24 Weeks in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive and Prior Relapser Patients With Genotype 1 Chronic Hepatitis C Infection

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are: 1. To evaluate the efficacy and safety of two different treatment regimens with BI 201335 (high dose given for 12 weeks or low dose given for 24 weeks both in combination with Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients. 2. Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV treatment.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	PegIFN/RBV	PegIFN/RBV for 48 weeks
DRUG	BI 201335	BI 201335 once daily high dose for 12 weeks
DRUG	BI 201335	BI 201335 once daily high dose for 12 weeks
DRUG	PegIFN/RBV	PegIFN/RBV for 48 weeks
DRUG	BI 201335	BI 201335 once daily low dose for 24 weeks

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-10-01
• First posted: 2012-05-31
• Last updated: 2013-02-26