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Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT00004695
Collaborator
(none)
48
Enrollment
30
Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency.

  1. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo.

Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months.

Patients are followed every 4 months for 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 1997
Study Completion Date :
Mar 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    PROTOCOL ENTRY CRITERIA:

    --Disease Characteristics--

    Documented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations

    In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures

    --Prior/Concurrent Therapy--

    No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day)

    Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required

    --Patient Characteristics--

    Life expectancy: At least 24 months

    Other: Not pregnant or nursing HIV negative

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai

    Investigators

    • Study Chair: Charlotte Cunningham-Rundles, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004695
    Other Study ID Numbers:
    • 199/13358
    • MTS-93-726-ME
    • MTS-FDR001162
    First Posted:
    Feb 25, 2000
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    May 1, 1999
    Keywords provided by , ,
    common variable immunodeficiency
    immunologic disorders and infectious disorders
    primary immunodeficiency disease
    rare disease
    Additional relevant MeSH terms:
    Immunologic Deficiency Syndromes
    Common Variable Immunodeficiency
    Interleukin-2

    Study Results

    No Results Posted as of Mar 25, 2015