Overview

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

Status:
Completed

Trial end date:
2011-08-01

Target enrollment:
0

Participant gender:
All

Summary

The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications. A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Boehringer Ingelheim

Treatments:

Interferons
Peginterferon alfa-2a
Ribavirin

Criteria

Inclusion criteria:

- chronic HCV genotype-1;

- high viral load

Exclusion criteria:

- Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening

- Previous treatment with protease inhibitor