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Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects With Primary Immunodeficiency Diseases

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Trial Profile

Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects With Primary Immunodeficiency Diseases

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Apr 2025

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Baxalta; Shire; Takeda

Most Recent Events

  • 14 Mar 2025 Results assessing the efficacy, safety, tolerability, and serum IgG trough levels of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% in US pediatric patients with primary immunodeficiency diseases (PIDDs) were published in the Journal of Clinical Immunology.
  • 21 Jun 2024 According to a Takeda media release, company announce that Health Canada has expanded the marketing authorization (NOC) for HyQvia (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in pediatric patients 2 years of age and older. Authorization was based on two pivotal studies in 66 patients ranging in age from 2 to 16 years.
  • 11 Apr 2023 According to a Takeda media release, based on this trial the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) to expand the use of HYQVIA to treat primary immunodeficiency (PI) in children 2-16 years old

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