This is a chronological listing of grants held by this department, with the most recent listed first. New grants appear in this list weekly and contribute related to the department's Research Profile. The source of grants for this application comes directly from your institution.
Ph 3, Random, Multi-Cntr Study to Eval Efficacy & Safety of Albumin Interferon A
Michael Fried; Betty Batey; Jama Darling; Karen Dougherty; Paul Hayashi; Luigi Troiani; Steven Zacks; Renee Blanchard3/7/2007 - 3/6/2010
|Sponsoring Organization:||Duke University|
|Awarding Organization Is:||University of North Carolina at Chapel Hill|
Betty M Batey (Investigator)
Jama M Darling (Investigator)
Michael W Fried (Lead Principal Investigator)
Paul Hideyo Hayashi (Investigator)
Steven L Zacks (Investigator)
Purpose: To evaluate the efficacy and safety of alb-IFN in combination with ribavirin compared with PEG-IFNa2a in combination with ribavirin in IFNa treatment-naïve subjects with chronic hepatitis C genotype 2/3. Participants: The target population to be enrolled in this trial is IFNa treatment-naïve subjects with chronic HCV genotype 2 or 3. 918 male and female patients age 18 or greater will take part in the study at 160 institutions. Procedures (methods): This is a Phase 3, randomized, multi-center study to evaluate the efficacy and safety of alb-IFN in combination with ribavirin compared with peginterferon a2a in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment-naïve. This study will randomize subjects in a 1:1:1 equal allocation to 1 of 3 treatment groups.