A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency
Condition: Immunologic Deficiency Syndrome
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Immune Globulin Intravenous (Human)
Intervention description: This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 13 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Primary immune deficiency

Summary:

      This study will compare the blood level of Gamunex in patients. Patients will take it as an
      injection under the skin or in a vein. The study will compare how safe and tolerable the two
      methods are in the patients. The patients in this study have a defect in their immune system
      from a genetic cause.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults and adolescents (age 13-75 inclusive) with a documented and confirmed
             pre-existing diagnosis of chronic primary immunodeficiency

          -  Previously or currently on IgG replacement therapy

          -  Documented (within 3 months) plasma IgG level of ≥500 mg/dL on current IgG therapy
             (IgG level can be obtained at the screening visit if documentation is not available)

          -  The medical records for all subjects within the previous 2 years should be available
             to document previous infections and treatment

        Exclusion Criteria:

          -  Clinical evidence of any significant acute or chronic disease that, in the opinion of
             the investigator, may interfere with successful completion of the trial

          -  The subject has a known adverse reaction to Gamunex or other blood products

          -  The subject has a history of blistering skin disease, clinically significant
             thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections or other
             disorders where subcutaneous therapy would be contraindicated

          -  The subject has known selective IgA deficiency with the exception of a known selective
             IgA deficient subject who has no previous documented eventful reaction to products
             containing IgA

          -  The subject is pregnant or lactating

          -  The subject has significant proteinuria and/or has a history of acute renal failure
             and/or severe renal impairment (BUN or creatinine more than 2.5 times the upper limit
             of normal) and/or on dialysis

          -  The subject has known substance or prescription drug abuse in the past 12 months

          -  The subject has a history of or current diagnosis of deep venous thrombosis

          -  The subject has an acquired medical condition that is known to cause secondary immune
             deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic
             or recurrent neutropenia (absolute neutrophil count less than 1000 x 10e6/L), or HIV
             infection/AIDS

          -  The subject is receiving any of the following medications: corticosteroids (long-term
             daily, >1 mg of prednisone equivalent/kg/day for >30 days) (intermittent courses would
             not exclude subject); immunosuppressants; or immunomodulators

          -  The subject has non-controlled arterial hypertension (systolic blood pressure >160
             mmHg and/or diastolic blood pressure >100 mmHg)

          -  The subject has anemia (hemoglobin <10 g/dL) at screening

          -  The subject has participated in another clinical trial within 30 days prior to
             screening (imaging studies without investigative treatments are permitted) or has
             received any investigational blood product within the previous 3 months