Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to determine a dose of weekly subcutaneously administered Immune
      Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%)
      that produces steady-state AUC of total IgG that was non-inferior to that of the regularly
      administered intravenous dose of Immune Globulin Injection (Human), 10%
      Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency
      subjects. This study was also designed to determine steady state trough total IgG levels
      after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety
      and tolerability of IGSC 20%.
    

Detailed description: 
      This was a prospective, multi-center, open-label, single-sequence, 6-month, pharmacokinetic,
      safety and tolerability study of IGSC 20% in subjects with primary immunodeficiency.
      Approximately 50 subjects were to be enrolled in order to have approximately 30 adult
      subjects and 12 to 18 pediatric subjects (age 2-16 years) completing treatment with
      subcutaneously administered IGSC 20%.

      This study included 3 treatment phases: Run-In Phase, IV Phase (IV administration of IGIV-C
      10% treatment), and SC Phase (SC administration of IGSC 20%).

      Subjects, depending on their current IgG treatment regimen, might be required to enter the
      Run-In Phase to receive IV IGIV-C 10% treatment (Sponsor provided) to achieve an
      approximately steady-state condition prior to entering the IV Phase. They then entered the IV
      Phase to determine the AUC profiles of IV infusions of IGIV-C 10%.

      Subjects with a qualifying IV IGIV-C 10% treatment regimen (on stable IGIV-C 10% doses of
      300-800 mg/kg) entered the IV Phase directly where they will receive IGIV-C 10%. In the IV
      Phase, steady-state IV PK assessments, including AUC, were to be performed.

      After completing the IV Phase, subjects entered the SC Phase to receive weekly SC doses of
      IGSC 20% for at least 24 weeks.

      The PK profiles of total IgG following administration of both IV (IGIV-C 10%) administration
      and SC (IGSC 20%) administration were determined and compared after reaching approximate
      steady-state conditions.
    

Intervention name(s): IGIV-C 10%; IGSC 20%
Intervention type(s): Biological; Biological
Intervention description(s): IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen; IGSC 20% weekly infusions with dose calculated based on previous IgG regimen
Other intervention name(s): Immune Globulin Injection 10% Caprylate/Chromatography; Immune Globulin Subcutaneous 20% Caprylate/Chromatography
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment