A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.

Status:	Completed
Conditions:	Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 65
Updated:	8/3/2016
Start Date:	September 2006
End Date:	August 2008

A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1

This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor
pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of
PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be
randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug +
PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS +
COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will
receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week
experimental period. The anticipated time on study treatment is 3-12 months, and the target
sample size is <100 individuals.

Inclusion Criteria:

- adult patients, 18-65 years of age;

- CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;

- chronic liver disease consistent with CHC.

Exclusion Criteria:

- infection with any HCV genotype other than genotype 1;

- previous treatment for CHC;

- medical condition associated with chronic liver disease other than CHC;

- HIV, Hepatitis A, Hepatitis B infection.

We found this trial at

sites

Clinical Trial Facility in Chapel Hill North Carolina

Chapel Hill, North Carolina

from

Chapel Hill, NC