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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2023

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Bacterial infections; Immunodeficiency disorders
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors GC Pharma

    • Most Recent Events

    • 17 Dec 2023 According to a GC Biopharma media release, Dr. Elena Perez, MD is the lead investigator of this study.
    • 31 Jul 2023 According to a GC Biopharma media release, GC5107B has passed the U.S. Food and Drug Administration's preliminary review for marketing authorization and initiated the review of GC5107B for final approval.
    • 31 Jul 2023 According to a GC Biopharma media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of the Biologics License Application (BLA) for its GC5107B (Immune Globulin Intravenous (Human) for patients with primary humoral immunodeficiency (PI). The Prescription Drug User Fee Act (PDUFA) target action date is January 13, 2024.
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