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

Beth Israel Lahey Health

Status and phase

Completed

Phase 4

Conditions

Hepatitis C

Treatments

Drug: Interferon Alfacon-1 and Ribavirin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00266318

164-04

Details and patient eligibility

About

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

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria