Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Condition: Primary Immune Deficiency Disorders (PIDD)
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Intervention description: Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] is a clear or slightly opalescent, colorless to pale yellow sterile solution of 10% protein concentration of immunoglobulin G (100mg/mL). It is packaged as 5g in 50mL solution and 10g in 100mL solution. Dosing will be 300-800 mg/kg based on subject's prior dosing history. Infusions will be every 3 or 4 weeks.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 6 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: immunodeficiency; humoral immunity; antibody deficiency; PID; PIDD

Summary:

      The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous
      (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the
      treatment of patients with primary immune deficiency disorders (PIDD) when compared to
      historical control data.
    

Eligibility criteria:

        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.