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Phase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID)

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Trial Profile

Phase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 08 Jul 2022

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At a glance

  • Drugs Immune globulin (Primary) ; Hyaluronidase
  • Indications Immunodeficiency disorders
  • Focus Therapeutic Use
  • Sponsors Baxter Healthcare Corporation

Most Recent Events

  • 06 Jul 2022 According to a Takeda media release, based on four clinical trials(160602, 161101, 160603 and 160902) including this pivotal efficacy trial the Health Canada has issued the marketing authorization (Notice of Compliance) for HyQvia (Normal Immunoglobulin (Human) 10% & Recombinant Human Hyaluronidase solution for subcutaneous infusion) as replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult patients.
  • 06 Oct 2014 New trial record

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