| Eligibility |
Inclusion Criteria:
- Male or female, age = 6 and = 75, with a documented and confirmed pre-existing
diagnosis of chronic primary immune deficiency (PIDD) with a low total immunoglobulin
G (IgG) level and deficient antibody production before chronic therapy (i.e., X-linked
agammaglobulinemia, common variable immunodeficiency (CVID), Hyper IgM Syndrome with
immunoglobulin G (IgG) deficiency, etc).
- Currently on immune globulin intravenous (IGIV) replacement therapy at a fixed
interval and dosage with a total monthly dose of immune globulin intravenous (IGIV)
between 300 and 800 mg/kg that has been stable for at least 3 months prior to
screening.
- Documented (within 3 months) plasma immunoglobulin G (IgG) trough level of >500 mg/dL
on current immunoglobulin G (IgG) therapy [immunoglobulin G (IgG) levels may be
obtained at screening if previous results not available].
- Medical records documenting infections and treatment within the previous 2 years need
to be available for review.
- Subject or legal guardian(s) must have given written informed consent/assent.
- If a menstruating female, have a negative serum or urine pregnancy test within 7 days
prior to the first dose of Nabi-IGIV [immune globulin intravenous (Human) 10%] and
agree to use an acceptable method of contraception or be at least one year
post-menopausal or surgically sterile.
Exclusion Criteria:
- Received any blood product [other than immune globulin intravenous (IGIV)] within the
last 3 months prior to screening or received any investigational agent [other than
immune globulin intravenous (IGIV)] within the last four weeks prior to receiving
Nabi-IGIV [immune globulin intravenous (Human) 10%].
- Known history of medically significant adverse reactions to other immunoglobulin G
(IgG) or blood products.
- Known selective immunoglobulin A (IgA) deficiency, history of allergic reaction to
products containing immunoglobulin A (IgA) or has a history of antibodies to
immunoglobulin A (IgA).
- Known significant proteinuria and/or has a history of acute renal failure/or severe
renal impairment [blood urea nitrogen (BUN) or creatinine more than 1.5 times the
upper limit of normal].
- Known history or current diagnosis of deep venous thrombosis.
- Known medical condition that is known to cause secondary immune deficiency, such as
chronic lymphocytic leukemia, lymphoma, multiple myeloma, human immunodeficiency virus
(HIV) infection, acquired immunodeficiency syndrome (AIDS), or chronic or recurrent
neutropenia (absolute neutrophil count less than 500 mm3).
- Current daily use of corticosteroids (> 10 mg of prednisone equivalent /day for > 30
days), immunosuppressants or immunomodulators. (Intermittent corticosteroid use during
the study is allowable, if medically necessary.)
- Known non-controllable arterial hypertension (systolic blood pressure (BP) > 160 mmHg
and /or diastolic BP >100 mmHg.)
- Known anemia at screening (hemoglobin <10 g/dL).
- Subject is pregnant or lactating.
- Known history of illicit drug use within 3 months prior to the administration of the
investigational product and for the study duration.
- Have any condition judged by the study physician to preclude participation in the
study, including any psychological disorder, which might hinder compliance.
- Known active viral or bacterial infection or symptoms/signs consistent with such an
infection within the two weeks prior to the initial dose of investigational product
infusion. Subjects may be on antibiotics as long as signs/symptoms of infection have
been absent for two weeks prior to the initial infusion of investigational product
(IP).
- Expectation of non-compliance with the protocol procedures and visit schedule.
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