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
Price :
$35
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At a glance
- Drugs Immune globulin (Primary)
- Indications Immunodeficiency disorders
- Focus Registrational; Therapeutic Use
- Sponsors Biotest AG
- 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