A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection

Status:	Completed
Conditions:	Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	8/3/2016
Start Date:	August 2009
End Date:	January 2012

A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio

This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with
RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and
Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus
infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591
300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12
hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the
safety and virological response data from Part 1 of the study are supportive, in Part 2
patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg
po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard
doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and
the target sample size is 100-500 individuals.

Inclusion Criteria:

- adult patients, >=18 years of age;

- chronic hepatitis C, genotype 1;

- treatment-naive.

Exclusion Criteria:

- liver cirrhosis and other forms of liver disease;

- HIV infection;

- hepatocellular cancer;

- cardiac disease.

We found this trial at

sites

Clinical Trial Facility in Detroit Michigan

Detroit, Michigan

from

Detroit, MI