Phase 4
Completed N=115
PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00087633 ↗
Enrolled (actual)
115
Serious AEs
40.4%
Results posted
Jan 2011
Primary outcomePrimary: Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV) — 61.8; 65.0 percentage of participants — p=0.725
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV) |
61.8; 65.0 | 0.725 |
| SECONDARY Summary of Virologic Response |
4; 0; 14; 4; 13; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00087633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.