Completed

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

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What is being tested

PEG-interleukin-2

Drug
Who is being recruted

Immunologic Deficiency Syndromes+9

+ Infections

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Over 2 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 1997
See protocol details

Summary

Principal SponsorIcahn School of Medicine at Mount Sinai
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1997

Actual date on which the first participant was enrolled.

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

NCT00004695
Principal SponsorIcahn School of Medicine at Mount Sinai
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 2 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immunologic Deficiency SyndromesInfectionsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesGenetic Diseases, InbornPrimary Immunodeficiency DiseasesCommunicable DiseasesImmune System DiseasesCommon Variable ImmunodeficiencyRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers