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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Mount Sinai School of Medicine |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004695 |
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 |
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Common Variable Immunodeficiency |
Drug: PEG-interleukin-2 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Estimated Enrollment: | 48 |
Study Start Date: | September 1997 |
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.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 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 |
common variable immunodeficiency immunologic disorders and infectious disorders primary immunodeficiency disease rare disease |
Analgesics, Non-Narcotic Interleukin-2 Rare Diseases Peripheral Nervous System Agents |
Analgesics Common Variable Immunodeficiency Immunologic Deficiency Syndromes |
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 |