A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

Completed · Phase 3

Conditions studied: Hepatitis C, Chronic

In brief

This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

Key facts

Study ID

NCT01853254

Run by

Hoffmann-La Roche

People needed

272

Starts

2003-09-01

Expected to finish

2011-09-01

Last updated by the study team

2013-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, ≥ 18 years of age.
• Chronic hepatitis C.
• Compensated liver disease (Child-Pugh Class A).
• Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
• Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
• Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
• For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
• Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.

You may not qualify if…

• Pregnant or breastfeeding women.
• Male partners of women who are pregnant.
• Patients with hemoglobinopathies.
• Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
• Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
• Liver disease other than chronic hepatitis C, including hepatic carcinoma.

Where it is running

• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Boise, Idaho, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Framingham, Massachusetts, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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