Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT01853254
Start Date
September 1 2003
End Date
September 1 2011
Last Update
September 4 2013
Active Locations (67)
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1
Birmingham, Alabama, United States, 35295-0005
2
La Jolla, California, United States, 92037-1030
3
Long Beach, California, United States, 90822
4
San Diego, California, United States, 92123