PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
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|ClinicalTrials.gov Identifier: NCT00087633|
Recruitment Status : Completed
First Posted : July 14, 2004
Results First Posted : January 24, 2011
Last Update Posted : January 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: peginterferon alfa-2a [Pegasys] Drug: Copegus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087633
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|Study Director:||Clinical Trials||Hoffmann-La Roche|