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

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004695 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label

Condition ^ICMJE

Common Variable Immunodeficiency

Intervention ^ICMJE

Drug: PEG-interleukin-2

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004695

Responsible Party

Study ID Numbers ^ICMJE

199/13358, MTS-93-726-ME, MTS-FDR001162

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Mount Sinai School of Medicine

Investigators ^ICMJE

Study Chair:

Charlotte Cunningham-Rundles

Mount Sinai School of Medicine

Information Provided By

FDA Office of Orphan Products Development

Verification Date

May 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP