NCT00266318

Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy

A Phase 4 Open-Label Pilot Study of the Safety and Tolerability of High Dosage of CIFN Plus RBV Administered Daily for 48 Weeks in HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Pegylated Interferon Alfa Plus RBV Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Beth Israel Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Interferon Alfacon-1 and Ribavirin

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-12-16
• Last updated: 2008-04-17

Locations

1 site across 1 country: United States