Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days. This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks
Cedars-Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
St. Louis University
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Safety
Time frame: Week 52
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Duke University Medical Center
Durham, North Carolina, United States
The Liver Institute at Methodist Dallas
Dallas, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Fundacion de Investigacion de Diego
San Juan, Puerto Rico