Status: Recruiting

Official Title: An open-label study of the safety of Pegasys alone or in combination with ribavirin in patients with chronic hepatitis C who have participated in previous studies

Brief Summary: This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy,at a maximum dose of 180 micrograms weekly, or combination therapy with Copegus ,800-1200mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed approved treatment duration of 24 weeks in genotype 2/3 and 48 weeks in genotype non-2/3 with a treatment-free follow up period of 24 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Phase: 3

Study Type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study

Condition: Hepatitis C, Chronic

Intervention Type: Drug

Intervention Name: ribavirin [Copegus]

• adult patients, >=18 years of age;
• CHC patients with compensated liver disease (Child-Pugh A) who have participated in a donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate after completion of the donor protocol.

• evidence of decompensated liver disease (Child B or C cirrhosis).

This trial will be conducted at the following locations:

• MANHASSET 11030
• SALT LAKE CITY
• SAN FRANCISCO
• NASHVILLE
• SAN ANTONIO
• SACRAMENTO
• RICHMOND
• BALTIMORE
• PORTLAND
• CORONADO
• PROVIDENCE
• NEW YORK
• CHAPEL HILL

• BERLIN 13353
• KÖLN
• FRANKFURT AM MAIN

• VANCOUVER V5Z 1H2
• TORONTO
• TORONTO
• VANCOUVER

• VANDOEUVRE-LES-NANCY 54511
• CRETEIL
• PESSAC
• CLICHY
• PARIS

• BADALONA 08915
• BARCELONA
• VALENCIA
• MADRID
• SEVILLA

• WIEN 1090