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

Phase 4 Completed 115 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2004-10
Primary completion: 2008-10
Completion: 2008-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Prophylaxis Arm vs Observation Arm; p = 0.725; Mean Difference (Final Values) -3.2 (95% CI -20.8 to 14.4); Cochran-Mantel-Haenszel NCT00087633 ↗

paper On an intent-to-treat basis, significant HCV recurrence at 120 weeks was similar in the prophylaxis (61.8%) and observation arms (65.0%, P = 0.725). PMID 21506241 ↗

Publications

Bzowej N, Nelson DR, Terrault NA, Everson GT, Teng LL, Prabhakar A, Charlton MR; PHOENIX Study Group. PHOENIX: A randomized controlled trial of peginterferon alfa-2a plus ribavirin as a prophylactic treatment after liver transplantation for hepatitis C virus. Liver Transpl. 2011 May;17(5):528-38. doi: 10.1002/lt.22271.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Ribavirin	Small molecule	1200 mg	Oral