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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: peginterferon alfa-2a [Pegasys]
* Drug: Copegus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: peginterferon alfa-2a [Pegasys]<br>* 135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks<br>Drug: Copegus<br>* 400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 120 weeks postrandomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up |