Status:
COMPLETED
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 an...
Eligibility Criteria
Inclusion
- (Abbreviated due to space constraints.)
- 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
- 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
- New onset diabetes
- Unstable or uncontrolled thyroid disease
- Presence or history of non-HCV chronic liver disease
- History of unstable or deteriorating cardiac or cerebrovascular disease within 6 months before Screening
- Current or history of neurologic disorder within the last 2 years
- History of seizures within the past 5 years
- History of hemoglobinopathies
- 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
- A disease known to cause significant alteration in immunologic function including hematologic malignancy, sarcoidosis or autoimmune disorder
- History or evidence of retinopathy
- History of major organ transplantation with an existing functional graft
- Concurrent therapy with immunosuppressive drugs or cytotoxic agents
- 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
- Pregnant or lactating women
- Male partners of women who are pregnant
- Known sensitivity to Infergen or IFN-α or to E. coli-derived products
- 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
- 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).
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT00086541
Start Date
June 1 2004
End Date
January 1 2007
Last Update
November 25 2019
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