Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy
Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to evaluate the safety and tolerability of combination
therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin
(based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are
non-responders to previous pegylated interferon alfa plus ribavirin therapy.
This is an open-label, multicenter study. All subjects will receive Infergen 24 mcg
administered by injection daily plus ribavirin 800-1400 mg (based on body weight)
administered by mouth daily for 48 weeks
* If any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of Infergen by
week 4, as determined by the principal investigator, then the dosage of Infergen will be
changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body
weight) administered by mouth daily for 48 weeks