A Clinical Study of Intravenous Immunoglobulin (NCT00468273) | Clinical Trial Compass
CompletedPhase 3
A Clinical Study of Intravenous Immunoglobulin
United States57 participantsStarted 2006-11
Plain-language summary
The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) \[IGIV\], 5% Solution Omr-IgG-amâ„¢ in patients with primary immunodeficiency diseases.
Who can participate
Age range3 Years – 75 Years
SexALL
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The following list is incomplete. A complete list is in the protocol.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 i…