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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086541
• Other study ID #: IRHC-001
• Secondary ID: DIRECT 1
• Status: Completed
• Phase: Phase 3
• Start date: June 2004
• Est. completion date: January 2007

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

(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-a 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).

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.