Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy

November 21, 2019 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

515

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

(Abbreviated due to space constraints.)

Inclusion Criteria:

  1. Signed informed consent form
  2. Male or female 18 yrs. of age or older
  3. Chronic HCV infection based on documented history of positive serum anti-HCV antibody test and/or detectable levels of HCV RNA
  4. Documented virologic nonresponse to past treatment with PEGASYS plus ribavirin or PEG-Intron plus ribavirin

  5. Previously treated w/either of the following starting doses of pegylated interferon alpha:

    1. ≥ 1.5 µg/kg/week PEG-Intron or dose consistent with the package insert or,
    2. ≥ 180 µg/week PEGASYS
  6. Detectable plasma HCV RNA level at screening visit
  7. Liver biopsy histologically documenting chronic liver disease consistent with chronic HCV infection
  8. 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:

  1. Any history of decompensated liver disease
  2. Any of a variety of laboratory abnormalities assessed through blood sample at screening
  3. 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
  4. Patients who had undetectable HCV RNA levels during prior pegylated interferon alfa plus ribavirin treatment but who relapsed during follow-up
  5. Significant depression in the last 2 years
  6. Patients treated for HCV infection within 3 months before screening (w/the exclusion of over-the-counter therapies)
  7. Patients who have been on any experimental protocol or therapy within 28 days before screening
  8. Use of colony-stimulating factor agents or other therapeutic agents that might artificially elevate laboratory parameters within 3 months before screening
  9. Known human immunodeficiency virus (HIV) infection or positive HIV antibody test at screening
  10. Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at screening
  11. New onset diabetes
  12. Unstable or uncontrolled thyroid disease
  13. Presence or history of non-HCV chronic liver disease
  14. History of unstable or deteriorating cardiac or cerebrovascular disease within 6 months before Screening
  15. Current or history of neurologic disorder within the last 2 years
  16. History of seizures within the past 5 years
  17. History of hemoglobinopathies
  18. History of malignancy within the last 5 years with the exception of localized basal or squamous cell carcinoma & fully resected, localized malignancy not requiring active treatment & with no evidence of recurrence
  19. A disease known to cause significant alteration in immunologic function including hematologic malignancy, sarcoidosis or autoimmune disorder
  20. History or evidence of retinopathy
  21. History of major organ transplantation with an existing functional graft
  22. Concurrent therapy with immunosuppressive drugs or cytotoxic agents
  23. Alcohol and/or drug abuse w/in the past year, that in the opinion of the Investigator or the Sponsor may negatively affect patient compliance
  24. Pregnant or lactating women
  25. Male partners of women who are pregnant
  26. Known sensitivity to Infergen or IFN-α or to E. coli-derived products
  27. Patients who, in the opinion of the Investigator or the Sponsor, are not suitable candidates for enrollment or who would not comply w/the requirements of the study
  28. Patients who have not responded to a course of daily Infergen (9 or 15 µg) with or without ribavirin or who have relapsed after a course of daily Infergen (9 or 15 µg).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

July 2, 2004

First Submitted That Met QC Criteria

July 6, 2004

First Posted (Estimate)

July 7, 2004

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRHC-001
  • DIRECT 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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