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
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | 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
