NCT00004695

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (planned)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

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. Completion date provided represents the completion date of the grant per OOPD records

Conditions

• Common Variable Immunodeficiency

Interventions

Type	Name	Description
DRUG	PEG-interleukin-2

Timeline

• Start date: 1997-09-01
• Completion: 2000-03-01
• First posted: 2000-02-25
• Last updated: 2015-03-25