Title
A Clinical Study of Intravenous Immunoglobulin
A Clinical Study of Immune Globulin Intravenous (Human) Omr-IgG-am IGIV in Subjects With Primary Immune Deficiency Diseases
Phase
Phase 3Lead Sponsor
FFF EnterprisesStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Immunologic Deficiency SyndromesIntervention/Treatment
immune globulin (human) ...Study Participants
57The 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.
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 immunodeficiency diseases.
Approximately 50 subjects will be enrolled for 16 Months:
screening- 1 month treatment-12 months follow-up-3 months
Subjects will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IGIV infusions. Subjects treated every 21 days will receive 17 study IGIV infusions.
We will record the incidence of acute infections, especially acute serious bacterial infections, during the year each subjet is on study.
We will record the incidence of adverse events that occur during each infusion and up to 48 hours after each infusion.
At the time the study is explained to the subjects, each investigator will ask all subjects whose body weight is above 37 kg (or greater as defined by local standards) about their willingness to participate in the pharmacokinetic (PK) portion of the study. This will involve 4 additional visits after the 5th or 6th study IGIV infusion in order to draw blood samples for analysis.
IGIV infusions of 300-900 mg/kg every 3 or 4 weeks
Subjects with primary humoral immunodeficiency
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.
