The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.
The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
subcutaneous continuous infusion at one of three doses for 48 weeks
1.5 μg/kg subcutaneous weekly for 48 weeks
All patients will receive oral ribavirin
Duke Clinical Research Institute
Durham, North Carolina, United States
Viral Load: Incidence of Sustained Virologic Response (SVR)
Time frame: 24 weeks after treatment is complete
Rapid Virologic Response (RVR)
Time frame: Study Week 4
Early Virologic Response (EVR)
Time frame: Study week 12
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pump delivery system for continuous subcutaneous infusion of interferon alfa-2b