A Clinical Study of Intravenous Immunoglobulin

Completed · Phase 3

Conditions studied: Immunologic Deficiency Syndromes

In brief

The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) \[IGIV\], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.

Key facts

Study ID

NCT00468273

Run by

FFF Enterprises

People needed

57

Starts

2006-11-01

Expected to finish

2009-08-01

Last updated by the study team

2014-08-11

Who can join

Age: 3 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 3 to 75 years and weigh at least 27 kg.
• Confirmed clinical diagnosis of a Primary Immune Deficiency disease including hypogammaglobulinemia, preferably with documented antibody deficiency, or agammaglobulinemia.
• Has been receiving licensed IGIV for at least 3 months prior to this study.
• Trough IgG levels, dose of IGIV, and treatment intervals for the last 2 consecutive licensed IGIV treatments must be documented.
• The subject or legal guardian has signed the informed consent form. If appropriate, the subject has signed a child assent form.
• The subject or legal representative has signed the HIPAA declaration.

You may not qualify if…

• Subjects with isolated IgG subclass deficiency or specific antibody deficiency without hypogammaglobulinemia will not be eligible.
• The subject has a history of hypersensitivity or persistent or repeated adverse reactions to human immunoglobulin.
• The subject has selective IgA deficiency, history of reaction to products containing IgA, or is known to have antibodies to IgA.
• The subject is currently participating, or has participated within the previous 30 days, in another clinical study of an investigational product or device.
• The subject is pregnant or is nursing. Women of childbearing potential must agree to using a method of contraception.
• The subject has had an acute bacterial infection within 28 days of screening.
• The subject is seropositive for any of the following at screening:
• Antibodies to HIV 1\&2
• Antibodies to HCV
• HbsAg
• The subject, at screening, has alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal.
• The subject has severe renal impairment.
• The subject has a history of DVT, thrombotic or thrombic complications of IGIV therapy.
• The subject suffers from any acute or chronic medical condition that, in the opinion of the investigator, may interfere with the conduct of the study.
• The subject has an acquired medical condition known to cause secondary immune deficiency or otherwise increase the subject's risk of infection.

Where it is running

• Mattel Children's Hospital of UCLA — Los Angeles, California, United States
• 1st Allergy and Clinical Research Center — Centennial, Colorado, United States
• Allergy Associates of the Palm Beaches — North Palm Beach, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Optimed Research, LLC — Columbus, Ohio, United States
• Pediatric Allergy Immunology Associates — Dallas, Texas, United States
• Allergy, Asthma and Immunology Clinic PA — Irving, Texas, United States
• University of Toronto — Toronto, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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