Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)

Phase 3 Completed 125 enrolled Merck Sharp & Dohme LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence.

Timeline

Start: 2006-05
Primary completion: 2009-07
Completion: 2009-07

Publications

Results Gordon FD, Kwo P, Ghalib R, Crippin J, Vargas HE, Brown KA, Schiano T, Chaudhri E, Pedicone LD, Brown RS Jr. Peginterferon-alpha-2b and ribavirin for hepatitis C recurrence postorthotopic liver transplantation. J Clin Gastroenterol. 2012 Sep;46(8):700-8. doi: 10.1097/MCG.0b013e31825833be.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	1.5 ug/kg	Subcutaneous
Subject	Ribavirin	Small molecule	800 mg	Oral
Subject	Ribavirin	Small molecule	1000 mg	Oral
Subject	Ribavirin	Small molecule	1200 mg	Oral

Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)

Summary

Timeline

Publications

Drugs

Indications