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

Hoffmann-La Roche115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a [Pegasys]DRUG

135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks

CopegusDRUG

400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

Unnamed facility

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)

Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2. Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe. Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis.

Time frame: 120 weeks postrandomization

Secondary Outcomes

Summary of Virologic Response

Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment.

Time frame: After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up

Data from ClinicalTrials.gov

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