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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)

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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