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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: 12 Sep 2024

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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

  • 09 Sep 2024 According to a GC Biopharma media release, ALYGLO was approved by the U.S. Food and Drug Administration (FDA) on Dec. 15, 2023 and the company announced the launch and distribution of its immunoglobulin (IG) product ALYGLO for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI).
  • 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.

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