Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED) (Pegade)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: October 12, 2005
Last Update Posted: March 9, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label, controlled pilot trial designed to evaluate the effect of infliximab induction therapy on sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus ribavirin in a group of 96 therapy-naïve subjects with genotype 1 hepatitis C virus (HCV) infection and high serum tumor necrosis factor (TNF)-alpha values.
|Hepatitis C, Chronic||Drug: Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin Drug: Combination of (a) pegylated interferon alfa-2b and (b) ribavirin||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Effect of Infliximab in Hepatitis-C Genotype 1 Naïve Patients With High TNF-alpha on the Efficacy of Pegylated Interferon Alfa-2b/Ribavirin Therapy|
Resource links provided by NLM:
Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Interferon Alfa-2b Infliximab Peginterferon Alfa-2bU.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Proportion of subjects who have achieved sustained virological response (SVR) in the infliximab (induction dose) plus PEGETRON and the PEGETRON groups at 24 weeks post treatment end [ Time Frame: 24 weeks after completion of up to 48 weeks of PEGETRON therapy ]
Secondary Outcome Measures:
- Early virological response (EVR) [ Time Frame: Week 12 of PEGETRON treatment period ]
- Safety parameters [ Time Frame: During 48-week PEGETRON treatment period and 24-week follow up ]
|Study Start Date:||July 2005|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Remicade induction dose at Day -7 prior to initiation of PEGETRON treatment for up to 48 weeks
Drug: Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin
Active Comparator: Arm B
PEGETRON treatment for up to 48 weeks
Drug: Combination of (a) pegylated interferon alfa-2b and (b) ribavirin
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