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

Phase 2 Completed 25 enrolled Boehringer Ingelheim

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2012-02
Primary completion: 2013-08
Completion: 2013-08

Publications

Yatsuhashi H, Kodani N, Ugai H, Omata M. Open-label phase 2 study of faldaprevir, deleobuvir and ribavirin in Japanese treatment-naive patients with chronic hepatitis C virus genotype 1 infection. Hepatol Res. 2016 Mar;46(3):E189-93. doi: 10.1111/hepr.12535. Epub 2015 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deleobuvir	Small molecule	600 mg	—
Subject	Faldaprevir	Small molecule	80 mg	—
Subject	Faldaprevir	Small molecule	120 mg	—
Background	Peginterferon alfa-2a	Protein / enzyme biologic	—	—
Background	Ribavirin	Small molecule	—	—

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

Summary

Timeline

Publications

Drugs

Indications