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

Primary Purpose

Common Variable Immunodeficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEG-interleukin-2
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Variable Immunodeficiency focused on measuring common variable immunodeficiency, immunologic disorders and infectious disorders, primary immunodeficiency disease, rare disease

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    Icahn School of Medicine at Mount Sinai
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004695
    Brief Title
    Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1997 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2000 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Icahn School of Medicine at Mount Sinai

    4. Oversight

    5. 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. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Variable Immunodeficiency
    Keywords
    common variable immunodeficiency, immunologic disorders and infectious disorders, primary immunodeficiency disease, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    PEG-interleukin-2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charlotte Cunningham-Rundles
    Organizational Affiliation
    Icahn School of Medicine at Mount Sinai
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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