A Clinical Study of Intravenous Immunoglobulin

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FFF Enterprises
• Collaborator: OMRIX Biopharmaceuticals
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

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 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.