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An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)

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Trial Profile

An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2023

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Biotest AG

    • Most Recent Events

    • 01 Apr 2023 Results of a subcohort analysis assessing the efficacy, pharmacokinetics and safety BT595 administered in children with primary immunodeficiency disease, published in the Journal of Clinical Immunology.
    • 01 Oct 2022 Primary endpoint has been met (Rate of acute serious bacterial infections) , according to Results published in the Vox Sanguinis
    • 01 Oct 2022 Results published in the Vox Sanguinis

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