Boehringer Ingelheim has announced the study outline for Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor to treat chronic genotype-1 hepatitis C.

The multiple randomised, double-blind, placebo-controlled trials will evaluate the drugin combination with pegylated-interferon and ribavirin, the current standard of care for hepatitis C.

The Phase III trials will consist of two studies in treatment-naïve patients and one study in treatment-experienced chronic genotype-1 hepatitis C patients.

The two studies in treatment-naïve patients will be conducted in the European Union, Japan, US, Canada, Taiwan and Korea, while the study in treatment-experienced patients will be conducted globally.

BI 201335 will be dosed once-daily at either 120mg or 240mg in combination with pegylated-interferon and ribavirin; treatment durations will range from 24 to 48 weeks.

The primary endpoint of each trial is sustained viral response, which is considered viral cure.

The studies form a part of broader Phase III trial programme expected to begin in the second quarter of 2011.

Boehringer has also announced that the US Food and Drug Administration has granted fast-track designations for BI 201335 plus standard-of-care, and as part of the interferon-free combination with the polymerase inhibitor, BI 207127, as a treatment for chronic genotype-1 hepatitis C.

Boehringer Ingelheim is developing BI 207127, an oral hepatitis C virus polymerase inhibitor that has completed Phase I clinical trials.

Hepatitis C is an infectious disease of the liver, and a leading cause of chronic liver disease and liver transplant. Around 170 million people are estimated to be chronically infected with Hepatitis C globally.