PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | October 2004 |
| End Date: | October 2008 |
A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C
This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of
prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to
initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection.
The anticipated time on study treatment was 3-12 months, and the target sample size was
100-500 individuals.
prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to
initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection.
The anticipated time on study treatment was 3-12 months, and the target sample size was
100-500 individuals.
Inclusion Criteria:
- Adult patients at least 18 years of age
- Positive hepatitis C virus RNA at pre-transplantation
- Primary, single-organ recipient (cadaveric donor)
- Liver transplant between 10 and 16 weeks before treatment initiation
Exclusion Criteria:
- Multi-organ or re-transplant recipient
- Evidence of current hepatitis B infection
- Seropositive for human immunodeficiency (HIV) infection
We found this trial at
25
sites
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