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TERMINATEDPHASE1

Safety Study of Low Dose Interleukin 2 (IL-2) Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I

A Phase I Study of Low Dose Interleukin 2 (IL-2)Monotherapy, Followed by IL-2 Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I Infection

NCT00277758•Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

This is a treatment study trial, in which we will assess the safety and tolerability of daily dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV for 48 weeks in the treatment of chronic Hepatitis C.

Detailed Description

This is a single center study of 12 weeks of IL-2 lead in immunotherapy followed by 48 weeks of IL2 immunotherapy in combination with Pegylated Interferon Alpha (PEG-IFN-alpha) /Ribavirin (RBV) antiviral therapy for the treatment of individuals infected with Hepatitis C virus (HCV) genotype I. The study is designed to determine whether immunotherapy immunotherapy with low dose daily IL-2 can be safely added to the standard antiviral therapy of 48 weeks of PEG-IFN and RBV. Because IL-2 targets recently antigen- activated T cells, IL-2 therapy will be initiated 12 weeks before PEG-IFN/RBV therapy, when HCV antigen load is high, to activate and expand HCV antigen-specific T cells prior to the initiation of antiviral therapy.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women, age \>18 years to \< 65 years.
•Ability and willingness to sign an informed consent.
•Hepatitis C antibody positive status confirmed by the NYPH laboratory.
•Genotype 1 HCV confirmed by the NYPH laboratory using the DupliType assay as performed by Quest Diagnostics.
•Liver biopsy demonstrating chronic hepatitis but without cirrhosis within 2 years of enrollment.
•Prothrombin time \< 3 seconds longer than control.
•Platelet count ≥75,000 mm3
•Neutrophil count ≥ 1000/mm3
•Hemoglobin ≥12 g/dL for women and ≥13 g/dL for men
•Subject must agree not to participate in a conception process (defined as active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization etc.) while on study drugs and for 6 months following permanent discontinuation of study therapy.
+4 more criteria

Exclusion Criteria

•Previous IFN-alpha, RBV or IL2 therapy
•Any active viral hepatitis other than hepatitis C virus infection, as defined by the presence of IgM antibody to Hepatitis A Virus (HAV) within 30 days of enrollment, or Hepatitis B Virus Surface Antigen (HBsAg) positivity, or positive plasma HBV DNA by PCR methodology when HB core antibody is the only serologic marker of HBV infection within 30 days of entry.
•ALT and AST \> 5x ULN, total bilirubin \> 1.5 x ULN
•Signs/symptoms of advanced liver disease.
•Uncontrolled infection, except hepatitis C
•HIV infection as determined by HIV ELISA \& Western blot assay, and confirmed by plasma HIV assay (PCR or bDNA)
•Cardiac condition that cannot be controlled by medication: Because of the risk of anemia associated with RBV use and the potential to induce cardiac ischemia, subjects with a positive cardiac stress test are ineligible. Therefore, subjects \> 40 years of age with ≥ 1 risk factor for ASHD (i.e., hyperlipidemia, hypertension, smoking history, family history) should have an EKG preformed. If the EKG is abnormal and consistent with ischemic heart disease, the subject should have a cardiac stress test to R/O ASHD.
•CNS or psychiatric illness uncontrolled by medication. In particular, psychiatric illness, especially depression. Subjects with a psychiatric illness, a previous suicide attempt or hospitalization for a psychiatric Dx Will be enrolled at the discretion of the investigator.
•Concurrent therapy with any immune-modulating agents, e.g,. interleukins, interferons, therapeutic vaccines, corticosteroids, immunosuppressive agents (azathioprine, 6-mercaptopurine, Cyclosporine-A, FK506, Rapamycin, antilymphocyte antibodies).
•Pregnant or nursing women (all women of child bearing age should be using effective contraception)
+19 more criteria

Locations (1)

Weill Medical College of Cornell University

New York, New York, United States

Key Dates

Start Date

March 1, 2004

Primary Completion Date

July 1, 2006

Completion Date

August 1, 2006

Last Updated

March 7, 2008

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

Interleukin 2

BIOLOGICAL

Ribavirin

DRUG

Pegylated Interferon Alpha

BIOLOGICAL

Inteleukin-2

BIOLOGICAL

Ribavirin + Pegylated interferon-alpha

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Study of Low Dose Interleukin 2 (IL-2) Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I

Inclusion Criteria

Exclusion Criteria

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