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Pediatric Immunology / Allergy: Subcutaneous immunoglobulin therapy for patients with primary immune deficiency studied

10/01/2008

The UCLA Division of Pediatric Immunology/Allergy/Rheumatology in the David Geffen School of Medicine at UCLA is recruiting patients on an ongoing basis for a clinical trial measuring the efficacy of subcutaneous immunoglobulin to treat primary immune deficiency. The study uses an immunoglobulin product that has been approved by the Food and Drug Administration (FDA).

Immunoglobulin therapy

Patients with primary immune deficiency are unable to produce a sufficient supply of immunoglobulin, also known as antibodies, to fight infections. These patients must undergo immunoglobulin-replacement therapy using plasma donated by healthy individuals that has been prepared for intravenous use. The product is extremely safe and is tested for infectious agents.

The majority of immunoglobulin products are restricted for intravenous use. This therapy results in an initial high level of antibodies immediately following therapy, followed by a dramatic dip right before the next dose. Each process takes three-to-four hours to complete, and must be repeated every three-to-four weeks. Intravenous therapy may lead to side effects, including headaches, muscle aches and low-grade fevers.

An alternative immunoglobulin therapy introduces the product directly under the skin using a smaller needle and a pump. Known as subcutaneous infusion, this process works using a slow-release method. The doses are smaller and must be given more frequently, about once a week. Patients can choose to administer the therapies at home.

The purpose of the study is to determine how well an immunoglobulin agent approved by the FDA for intravenous use works when given subcutaneously. This product is known as GAMMAGARD and has been used safely for several years intravenously.

Study participation

The study seeks to enroll patients who suffer from primary immune deficiency and are currently receiving immunoglobulin therapy. Participants must be between 2 and 75 years of age. Certain conditions may make a patient ineligible to participate, including some allergic reactions, diseases of the liver or kidneys, anemia, malignancies and pregnancy. Potential participants are encouraged to discuss their health status with a team member to determine eligibility.

Once enrolled in the study, participants will receive the necessary therapies (including medical equipment for home use) free of charge. Additionally, patients will receive monetary compensation for each scheduled visit or home visit. Participants can expect to undergo between 12 and 15 visits to UCLA and must complete paperwork on a regular basis. Additional blood draws may be required.

Additional studies on immunoglobulin therapy are continually being added. Patients are encouraged to discuss with a team member their eligibility for future clinical trials of subcutaneous immunoglobulin.

Team members

Robert L. Roberts, M.D., Ph.D.
Clinical Professor
Department of Pediatrics
Division of Immunology/Allergy/Rheumatology
David Geffen School of Medicine at UCLA

Maria Garcia-Lloret, M.D.
Assistant Professor
Department of Pediatrics
David Geffen School of Medicine at UCLA

Kevin Wang, M.D.
Research Study Coordinator
Department of Pediatrics
David Geffen School of Medicine at UCLA

Contact information

For further information, patients should contact the study coordinator, who can review the details of the study and set up a telephone interview, if appropriate.

Department of Pediatrics
12-430 MDCC
Mattel Children’s Hospital at UCLA
Los Angeles, CA 90095

(310) 825- 6777 or (310) 825-6481

Physicians and patients are encouraged to contact the medical director to discuss their participation in this or future studies:

Robert Roberts, M.D., Ph.D.
rroberts@mednet.ucla.edu
(310) 825-6777 or (310) 825-6481





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