PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Copegus; Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00087633

ML18124

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Copegus

Drug: peginterferon alfa-2a [Pegasys]

2

No Intervention group