Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
Condition: Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Intervention description: IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min.
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: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Idiopathic (Immune) Thrombocytopenic Purpura; Immunoglobulin G

Summary:

      The objective of this study is to determine if the safety and tolerability of Immune Globulin
      Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at
      two different infusion rates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent from patient or legal guardian (according to institutional
             review board requirements)obtained prior to initiation of any study related procedures

          -  Male and female subjects age between 12 and 75 years

          -  Confirmed diagnosis of ITP logged in medical records available prior to entry into the
             trial.

          -  Patients must have a platelet count < 30 x Giga/L (this level can be higher if
             clinically indicated).

          -  Previously splenectomized patients may be included.

          -  Any previously conducted bone marrow aspirations if conducted following diagnosis of
             ITP must be consistent with the ITP diagnosis (increased or normal levels of
             megakaryocytes in otherwise normal bone marrow).

        Exclusion Criteria:

          -  History of allergic or other clinically significant reaction to human gamma globulin
             or other plasma proteins and/or blood products.

          -  Female patient who is pregnant or lactating or is not on an adequate program of
             contraception if of child-bearing potential.

          -  Documented history of selective immunoglobulin A (IgA) deficiency (serum <5.0 mg/dL)
             and known antibodies to IgA.

          -  Currently on intermittent prednisone therapy. Prednisone therapy is allowed only if
             the patient has been on stable daily doses of prednisone for the preceding month and
             maintains the same treatment regimen throughout the study.

          -  Renal or liver impairment defined by creatinine > 2.5 mg/dL, or direct bilirubin >1.5
             X the upper limit of normal or liver transaminases (AST or ALT) > 3 times the upper
             limit of normal.

          -  Received anti-D or IGIV infusions within the past 14 days

          -  Pre-treatment with the exception of acetominophen, routinely required to
             control/ameliorate IGIV infusion-related adverse events (AEs), or any patient who has
             been, unresponsive to IGIV therapy for their ITP

          -  History or clinical evidence of medical conditions felt to be the underlying cause of
             their thrombocytopenia. Such conditions commonly include systemic lupus erythematosus,
             history of chronic lymphocytic leukemia, dysplasia, agammaglobulinemia, treatment with
             heparin, quinidine, quinine, trimethoprim-sulfamethoxazole, or ticlopidine or any
             other drug thought to be the cause of patient's thrombocytopenia, congenital or
             hereditary thrombocytopenia, or pseudothrombocytopenia (clumping on peripheral blood
             smear)

          -  Conditions that could alter protein catabolism and/or immunoglobulin G (IgG)
             utilization (e.g. protein-losing enteropathies, nephrotic syndrome)

          -  Congestive heart failure (New York Heart Association Stage III or IV)

          -  Diabetes mellitus

          -  Paraproteinemia

          -  Concomitant nephrotoxic drugs

          -  Hemoglobin level more than 2g/L below the lower limit of normal.