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)

A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 678 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	BI 201335	BI 201335 once a day (QD) for 24 weeks
DRUG	Pegylated Interferon-alpha (IFN)	Pegylated Interferon-alpha for 48 weeks
DRUG	Ribavirin (RBV)	Ribavirin (RBV) for 24 or 48 weeks
DRUG	Placebo	Placebo to BI201335 for 24 weeks

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-02-01
• Completion: 2014-05-01
• First posted: 2011-05-24
• Last updated: 2016-08-29
• Results posted: 2015-10-28

Locations

116 sites across 12 countries: United States, Austria, Belgium, Canada, France, Germany, Japan, Portugal, Puerto Rico, Spain, Switzerland, United Kingdom