Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
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.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Study Start Date:||September 1997|
|Estimated Study Completion Date:||March 2000|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004695
|Study Chair:||Charlotte Cunningham-Rundles||Mount Sinai School of Medicine|