PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
|Hepatitis C, Chronic||Drug: peginterferon alfa-2a [Pegasys] Drug: Copegus||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C|
- Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV) [ Time Frame: 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.
- Summary of Virologic Response [ Time Frame: 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.
|Study Start Date:||October 2004|
|Study Completion Date:||October 2008|
Drug: peginterferon alfa-2a [Pegasys]
135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeksDrug: Copegus
400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks
|No Intervention: 2|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087633
Show 28 Study Locations
|Study Director:||Clinical Trials||Hoffmann-La Roche|