Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Immune Globulin Intravenous; Prometic's Immune Globulin Intravenous 10%
Intervention description: Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product; Liquid formulation of Prometic Immune Globulin Intravenous 10% (human) in 50 mL vials containing 100 mg/mL of immunoglobulin G (IgG)
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 2 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics
      (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal
      product [IMP]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is male or female between the ages of 2 and 80 years at Screening.

          2. Female subjects of childbearing potential must agree to employ adequate birth control
             measures, as determined by their IRB/IEC, for the duration of the study.

          3. The subject must have one of the following three diagnoses (isolated PIDD of other
             types will be excluded):

               -  Common variable immunodeficiency

               -  X-linked agammaglobulinemia

               -  Hyper-IgM syndrome and documented low IgG levels (<4.5 mg/mL [450 mg/dL]).

          4. Subjects must have been treated with a stable dose of immune globulin administered
             intravenously (IGIV) or subcutaneously (IGSC) and has documented trough or steady
             state IgG levels of ≥ 5 mg/mL.

        Exclusion Criteria:

          1. Subject has secondary immunodeficiency or has been diagnosed with dysgammaglobulinemia
             or isolated IgG subclass deficiency; has known hypoalbuminemia (<3 gm/dL),
             protein-losing enteropathy, or nephrotic syndrome.

          2. Subject has ever had a history of severe anaphylactic or anaphylactoid reaction to
             immunoglobulins or other blood products.

          3. Subject has a known history of immunoglobulin A (IgA) deficiency and known anti-IgA
             antibodies, thrombotic event, such as deep vein thrombosis, myocardial infarction,
             cerebrovascular accident, pulmonary embolism, at any time.

          4. Subject has received blood products except IGIV, IGSC, or albumin within the previous
             12 months or has participated in another study (except for IGIV, IGSC studies) within
             the previous 4 weeks.

          5. Subject has had cancer in the past 5 years, except for basal cell or squamous cell
             cancers of the skin.

          6. Subject has had a documented active infection within 7 days prior to Screening, or
             subject is on continuous prophylactic antibiotics.

          7. Subject is positive for human immunodeficiency virus (HIV)-1 or HIV-2, a positive
             hepatitis C virus (HCV) or hepatitis B virus (HBV).

          8. Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase
             (AST) >2.5 times the upper limit of normal (ULN).

          9. Subject has serum creatinine >1.5 times the ULN or a severe chronic condition such as
             renal failure with proteinuria.

         10. Subject has anemia with a hemoglobin level ≤8 g/dL.

         11. Subject has severe neutropenia with neutrophil count ≤1000 per mmᴧ3 or has lymphopenia
             with <500 per/ mmᴧ3.

         12. Subject is taking prednisone at a dose ≥0.15 mg/kg/day and receiving other
             immunosuppressive drugs or chemotherapy.

         13. Subject has known atrial fibrillation requiring anticoagulant therapy; congestive
             heart failure (New York Heart Association Class III/IV); cardiomyopathy; or cardiac
             arrhythmia associated with thromboembolic events, unstable or advanced ischemic heart
             disease, or hyperviscosity.

         14. Subject has known decreased Protein C and/or Protein S levels.

         15. Subject is positive for antibodies to β2GPI and/or β2GPI DI at Screening.

         16. Female subject who is pregnant, breast-feeding, or planning a pregnancy during the
             course of the study.

         17. A history of epilepsy or multiple episodes of migraine (defined as at least one
             episode within 6 months of enrolment) not completely controlled by medication, or any
             condition that is likely to interfere with evaluation of the IMP or satisfactory
             conduct of the study in the Investigator's opinion.