Status:
COMPLETED
A Clinical Study of Intravenous Immunoglobulin
Lead Sponsor:
FFF Enterprises
Collaborating Sponsors:
OMRIX Biopharmaceuticals
Conditions:
Immunologic Deficiency Syndromes
Eligibility:
All Genders
3-75 years
Phase:
PHASE3
Brief 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 dis...
Detailed Description
This is an open label, single-arm, prospective, multi-center, uncontrolled Phase III clinical study to evaluate the efficacy, pharmacokinetics and safety of Omr-IgG-am™ in patients with primary immuno...
Eligibility Criteria
Inclusion
- The following list is incomplete. A complete list is in the protocol.
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00468273
Start Date
November 1 2006
End Date
August 1 2009
Last Update
August 11 2014
Active Locations (10)
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1
Mattel Children's Hospital of UCLA
Los Angeles, California, United States, 90095-1752
2
1st Allergy and Clinical Research Center
Centennial, Colorado, United States, 80112
3
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States, 33408
4
Rush University Medical Center
Chicago, Illinois, United States, 60612