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NCT00004695 Clinical Trial

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

Common Variable Immunodeficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004695
Other study ID # 199/13358
Secondary ID MTS-93-726-MEMTS
Status Completed
Phase N/A
First received February 24, 2000
Last updated March 24, 2015
Start date September 1997
Est. completion date March 2000

Study information
Verified date May 1999
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date March 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility 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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PEG-interleukin-2

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai
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