NCT00004695

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 1997

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
Last Updated

March 25, 2015

Status Verified

May 1, 1999

First QC Date

February 24, 2000

Last Update Submit

March 24, 2015

Conditions

Common Variable Immunodeficiency

Keywords

common variable immunodeficiencyimmunologic disorders and infectious disordersprimary immunodeficiency diseaserare disease

Interventions

PEG-interleukin-2DRUG

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Common Variable ImmunodeficiencyImmune System DiseasesCommunicable DiseasesPrimary Immunodeficiency DiseasesRare Diseases

Interventions

interleukin-2, polyethylene glycol-modified

Condition Hierarchy (Ancestors)

Immunologic Deficiency SyndromesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Charlotte Cunningham-Rundles

    Icahn School of Medicine at Mount Sinai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

September 1, 1997

Study Completion

March 1, 2000

Last Updated

March 25, 2015

Record last verified: 1999-05