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A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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Trial Profile

A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs Immune globulin (Primary) ; Immune globulin (Primary)
  • Indications Chronic inflammatory demyelinating polyradiculoneuropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms ADVANCE-1; ADVANCE-CIDP 1
  • Sponsors Baxalta; Shire; Takeda

Most Recent Events

  • 27 Mar 2025 According to a Takeda media release, based on data rom this trial Health Canada has expanded the marketing authorization for HyQvia (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) for chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin (IVIG) to prevent relapse of neuromuscular disability and impairment in adults.
  • 18 Apr 2024 Results assessing Patient-reported Outcomes with Hyaluronidase-facilitated Subcutaneous Immunoglobulin 10% Maintenance Therapy for Chronic Inflammatory Demyelinating Polyradiculoneuropathy presented at the 76th Annual Meeting of the American Academy of Neurology 2024
  • 29 Jan 2024 Results published in a Takeda media release.

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