A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy

Bausch Health Americas, Inc.0 sites515 target enrollmentJune 2004

DrugsDaily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Hepatitis C
Sponsor: Bausch Health Americas, Inc.
Enrollment: 515
Primary Endpoint: Evaluate sustained virologic response (SVR) rate of daily Infergen at two dose levels plus ribavirin and no treatment in chronically HCV-infected patients who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients chronically infected with hepatitis C who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.

Patients are randomized 1:1:1 to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both administered daily) or no treatment for up to 48 weeks.

The protocol and informed consent form that will be used must be approved by the Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the study is initiated.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

January 2007

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch Health Americas, Inc.

Eligibility Criteria

Inclusion Criteria

•Signed informed consent form
•Male or female 18 yrs. of age or older
•Chronic HCV infection based on documented history of positive serum anti-HCV antibody test and/or detectable levels of HCV RNA
•Documented virologic nonresponse to past treatment with PEGASYS plus ribavirin or PEG-Intron plus ribavirin
•Previously treated w/either of the following starting doses of pegylated interferon alpha:
•≥ 1.5 µg/kg/week PEG-Intron or dose consistent with the package insert or,
•≥ 180 µg/week PEGASYS
•Detectable plasma HCV RNA level at screening visit
•Liver biopsy histologically documenting chronic liver disease consistent with chronic HCV infection
•All patients and all potentially fertile sexual partners of patients must use 2 reliable forms of effective contraception during the study \& for 6 months after cessation of the study drugs

Exclusion Criteria

•Any history of decompensated liver disease
•Any of a variety of laboratory abnormalities assessed through blood sample at screening
•Patients who prematurely discontinued, interrupted, or reduced the dose of their previous pegylated interferon alpha-based combination therapy due to noncompliance or safety and/or tolerability issues
•Patients who had undetectable HCV RNA levels during prior pegylated interferon alfa plus ribavirin treatment but who relapsed during follow-up
•Significant depression in the last 2 years
•Patients treated for HCV infection within 3 months before screening (w/the exclusion of over-the-counter therapies)
•Patients who have been on any experimental protocol or therapy within 28 days before screening
•Use of colony-stimulating factor agents or other therapeutic agents that might artificially elevate laboratory parameters within 3 months before screening
•Known human immunodeficiency virus (HIV) infection or positive HIV antibody test at screening
•Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at screening

Outcomes

Primary Outcomes

Evaluate sustained virologic response (SVR) rate of daily Infergen at two dose levels plus ribavirin and no treatment in chronically HCV-infected patients who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.

Secondary Outcomes

Evaluate safety & tolerability of therapy detailed in primary objective, and proportion of patients with (a) undetectable plasma HCV RNA levels at weeks 24 & 48 (b) abnormal baseline serum ALT levels that are normal at week 24, week 48 and weeks 48 & 72.