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

Completed · Phase 4

Conditions studied: Hepatitis C

In brief

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

Key facts

Study ID

NCT00266318

Run by

Beth Israel Medical Center

People needed

40

Starts

2005-12-01

Expected to finish

2007-05-01

Last updated by the study team

2008-04-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must have documented failure to respond to past treatment with a Pegylated IFN + RBV. Failure to respond to past treatment is defined as positive HCV RNA at 12 weeks and less than a 2 log drop from baseline; OR positive HCV RNA and greater than 2 log drop from baseline at week 12 and must have received 24 weeks of therapy and still have a positive HCV RNA
• Must have tolerated previous hepatitis C therapy
• Must be off hepatitis C therapy for 3 months prior to study participation
• Must have had a liver biopsy within the past 5 years

You may not qualify if…

• Decompensated liver disease
• Laboratory abnormalities as per protocol
• HIV+
• Autoimmune disease
• Unstable or deteriorating cardiovascular or cerebrovascular disease
• History of seizures in past 5 years
• Alcohol or drug abuse in past year
• Pregnant or lactating women

Where it is running

• Beth Israel Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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