NCT00905632

4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients

Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	BI 207127 middle dose +SOC	BI 207127 middle dose tid + SOC
DRUG	BI 207127 high dose+SOC	BI 207127 high dose tid +SOC
DRUG	Placebo + SOC	Placebo tid +SOC
DRUG	BI 207127 low dose + SOC	BI 207127 low dose tid + SOC

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-03-01
• First posted: 2009-05-20
• Last updated: 2016-04-19
• Results posted: 2016-04-19

Locations

18 sites across 3 countries: France, Germany, Switzerland