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

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
First received: February 24, 2000
Last updated: March 24, 2015
Last verified: May 1999

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.

Condition Intervention
Common Variable Immunodeficiency
Drug: PEG-interleukin-2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 48
Study Start Date: September 1997
Estimated Study Completion Date: March 2000
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


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004695

Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Study Chair: Charlotte Cunningham-Rundles Icahn School of Medicine at Mount Sinai
  More Information

ClinicalTrials.gov Identifier: NCT00004695     History of Changes
Other Study ID Numbers: 199/13358  MTS-93-726-ME  MTS-FDR001162 
Study First Received: February 24, 2000
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
common variable immunodeficiency
immunologic disorders and infectious disorders
primary immunodeficiency disease
rare disease

Additional relevant MeSH terms:
Common Variable Immunodeficiency
Immunologic Deficiency Syndromes
Immune System Diseases
Analgesics, Non-Narcotic
Antineoplastic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 22, 2016