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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2025

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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

  • 25 Jul 2025 Planned End Date changed from 1 Nov 2023 to 1 Nov 2026.
  • 25 Jul 2025 Planned primary completion date changed from 1 May 2023 to 1 May 2026.
  • 25 Jul 2025 Status changed from recruiting to active, no longer recruiting.

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