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

This study is ongoing, but not recruiting participants.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Mount Sinai School of Medicine
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004695

Purpose

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

Drug Information available for: Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label

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

Estimated Enrollment:	48
Study Start Date:	September 1997

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.

Eligibility

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

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

Contacts and Locations

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

Sponsors and Collaborators

FDA Office of Orphan Products Development

Mount Sinai School of Medicine

Investigators

Study Chair:

Charlotte Cunningham-Rundles

Mount Sinai School of Medicine

More Information

No publications provided

Study ID Numbers:	199/13358, MTS-93-726-ME, MTS-FDR001162
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004695 History of Changes
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

Study placed in the following topic categories:

Analgesics, Non-Narcotic
Interleukin-2
Rare Diseases
Peripheral Nervous System Agents

Analgesics
Common Variable Immunodeficiency
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Immunologic Deficiency Syndromes
Pharmacologic Actions
Interleukin-2
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Common Variable Immunodeficiency

ClinicalTrials.gov processed this record on May 07, 2009