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

This study has been completed.
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00086541
First received: July 2, 2004
Last updated: May 3, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 515
Study Start Date: June 2004
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

(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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00086541     History of Changes
Other Study ID Numbers: IRHC-001, DIRECT 1
Study First Received: July 2, 2004
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Chronic Hepatitis C
Liver
Pegylated
Interferon
Alpha
Ribavirin
Combination
Nonresponder
HCV
Infergen
SVR

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon alfacon-1
Interferon-alpha
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014