Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
Condition: Immunologic Deficiency Syndrome; Agammaglobulinemia; Severe Combined Immunodeficiency; Wiskott-Aldrich Syndrome; Common Variable Immunodeficiency
MeSH terms: Wiskott-Aldrich Syndrome; Agammaglobulinemia; Severe Combined Immunodeficiency; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine if the safety and tolerability of Immune Globulin
      Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at
      two different infusion rates. The primary objective is to compare the incidence and severity
      of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14
      mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
    

Detailed description: 
      This is a prospective, single blind, randomized, multi-center cross-over trial in patients
      with Primary Immune Deficiency. Patients with a confirmed diagnosis of primary Immune
      Deficiency will be treated with two daily infusions given 3-4 weeks apart at the fixed
      individual IGIV dose regimen (400-600 mg/kg) established prior to entry into the study. Any
      subject with an established dose in the range of 200-399 mg/kg will be assigned to receive
      400 mg/kg during the course of the study during the same dosing schedule established prior to
      entry into the study.

      After a screening period lasting not more than four weeks, patients will be randomized into
      one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C,
      10% dose at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min,
      whereas patients randomized to Group 2 will receive IGIV-C, 10% at a rate of 0.14 mL/kg/min
      on the first infusion day and then 0.08 mL/kg/min on the second infusion day. All patients
      just prior to each IGIV-C, 10% infusion will receive the same volume of 5% dextrose as
      calculated for their IGIV-C, 10% infusion and given at a target rate according to the schema
      below.

      Group 1:

        -  Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)

        -  Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)

      Group 2:

        -  Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)

        -  Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
    

Intervention name(s): Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified; Dextrose, 5% in Water
Intervention type(s): Drug; Drug
Other intervention name(s): Gamunex; IGIVnex; Gaminex; IGIV-C; Immune Globulin Intravenous (Human) , 10%; IGIV; BAY 41-1000; TAL-05-00004
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Primary Immune Deficiency; IGIV; Immunoglobulin G