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An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

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Trial Profile

An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 May 2023

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors GC Biopharma

Most Recent Events

  • 09 Jun 2022 Planned number of patients changed from 16 to 24.
  • 31 Jan 2021 Status changed from not yet recruiting to recruiting.
  • 08 Oct 2020 New trial record

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