Overview

POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).

Status:
Completed

Trial end date:
2010-11-01

Target enrollment:
0

Participant gender:
All

Summary

This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Interferon-alpha
Peginterferon alfa-2a
Ribavirin

Criteria

Inclusion Criteria:

- adult patients, >=18 years of age;

- positive serum HCV RNA.

Exclusion Criteria:

- co-infection with HIV or HBV (patients with a positive HBsAg);

- previous treatment with interferon, or peginterferon and/or ribavirin;

- severe hepatic dysfunction or decompensated cirrhosis of liver.