NCT01858961

Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients

A Phase III, Randomised, Open Label, Active-controlled Study of an Interferon-free Regimen of BI 207127 in Combination With Faldaprevir and Ribavirin Compared to Telaprevir in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive Patients With Chronic Genotype 1b Hepatitis C Virus 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• Status: Withdrawn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 aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	BI 201335	Once a day
DRUG	ribavirin	Twice a day
DRUG	BI 207127	Twice a day
DRUG	Telaprevir	Three times a day
DRUG	ribavirin	Twice a day
DRUG	Pegylated Interferon	Once a week

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-05-21
• Last updated: 2014-01-23

Locations

12 sites across 3 countries: Australia, Spain, Sweden