Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
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|ClinicalTrials.gov Identifier: NCT00004695|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
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 or disease||Intervention/treatment||Phase|
|Common Variable Immunodeficiency||Drug: PEG-interleukin-2||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||48 participants|
|Masking:||None (Open Label)|
|Study Start Date :||September 1997|
|Study Completion Date :||March 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004695
|Study Chair:||Charlotte Cunningham-Rundles||Icahn School of Medicine at Mount Sinai|