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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief 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 Summary:

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

Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: FDA Office of Orphan Products Development

Dates:
Date Received: February 24, 2000
Date Started: September 1997
Date Completion: March 2000
Last Updated: March 24, 2015
Last Verified: May 1999