Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 1999 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Mount Sinai School of Medicine
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: May 1999

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 Intervention
Common Variable Immunodeficiency
Drug: PEG-interleukin-2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 48
Study Start Date: September 1997
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.


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004695

Sponsors and Collaborators
Mount Sinai School of Medicine
Study Chair: Charlotte Cunningham-Rundles Mount Sinai School of Medicine
  More Information

No publications provided Identifier: NCT00004695     History of Changes
Other Study ID Numbers: 199/13358, MTS-93-726-ME, MTS-FDR001162
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
common variable immunodeficiency
immunologic disorders and infectious disorders
primary immunodeficiency disease
rare disease

Additional relevant MeSH terms:
Common Variable Immunodeficiency
Immunologic Deficiency Syndromes
Immune System Diseases
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 25, 2015