Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)
|ClinicalTrials.gov Identifier: NCT00378599|
Recruitment Status : Completed
First Posted : September 20, 2006
Results First Posted : July 16, 2010
Last Update Posted : April 6, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation Hepatitis C, Chronic Liver Cirrhosis||Drug: Combination of (a) pegylated interferon alfa-2b and (b) rebetol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROTECT - Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation: Efficacy and Safety in Hepatitis C Recurrence Therapy|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Resource links provided by the National Library of Medicine
Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Interferon Alfa-2b Peginterferon Alfa-2bU.S. FDA Resources
Experimental: PEG-Intron plus Rebetol (RBV)
PEG-Intron plus RBV treatment for up to 48 weeks with 24-week follow up. SCH 54031 PEG-Intron 1.5 ug/kg SC per week plus SCH 18908 REBETOL twice daily (BID) PO with food, dosed as followed: Weeks 1 and 2, RBV Dose 400 mg (2 capsules, 1 AM and 1 PM). At the end of Weeks 2 and 4 of Treatment (tx), a complete blood count (CBC) was performed. An increase in RBV dose was permitted only if the hemoglobin was >10 g/dL. At Weeks 3 and 4, RBV dose was 800 mg (4 capsules, 2 AM and 2 PM). From Weeks 5 to 48, RBV doses could be increased based on subject body weight. For subjects weighing <65 kg, maximum dose of RBV was to be 800 mg (4 capsules, 2 AM and 2 PM), for subjects weighing 65-85 kg, max dose of RBV was 1000 mg/day (5 capsules, 2 AM and 3 PM), for subjects weighing >85 kg, max dose of RBV was 1200 mg/day, 6 capsules, 3 AM and 3 PM).
Drug: Combination of (a) pegylated interferon alfa-2b and (b) rebetol
Primary Outcome Measures :
- A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment [ Time Frame: 24 weeks after completion of up to 48 weeks of therapy ]Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.
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