NCT01528735

This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	BI 207127 NA	one fix dose
DRUG	peginterferon	per package insert
DRUG	Ribavirin	per weight BID
DRUG	Ribavirin	per weight BID
DRUG	BI 207127 NA	one fix dose
DRUG	BI 201335 NA	high dose
DRUG	BI 201335 NA	low dose
DRUG	peginterferon	per package insert

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-02-08
• Last updated: 2016-04-13
• Results posted: 2016-04-13

Locations

5 sites across 1 country: Japan