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

Phase 4

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: peginterferon alfa-2a [Pegasys]; Drug: Copegus

• Registration Number: NCT00087633
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-07-12
• Study First Submitted QC: 2004-07-13
• Study First Posted: 2004-07-14
• Study Start: 2004-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-10-14
• Results First Submitted QC: 2010-12-22
• Results First Posted: 2011-01-24
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Copegus	-
1	peginterferon alfa-2a [Pegasys]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)	120 weeks postrandomization	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.

Secondary Outcome Measures

Name	Time	Method
Summary of Virologic Response	After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up	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.