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An Open-label, Multicenter, Phase 4 Study to Assess the Effects of a Prophylactic Immune Tolerizing Regimen in MPS II Treatment-Naive Patients Planned to Receive ELAPRASE Who Are at Risk of Developing Persistent Neutralizing Antibodies

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Trial Profile

An Open-label, Multicenter, Phase 4 Study to Assess the Effects of a Prophylactic Immune Tolerizing Regimen in MPS II Treatment-Naive Patients Planned to Receive ELAPRASE Who Are at Risk of Developing Persistent Neutralizing Antibodies

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 06 Mar 2025

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At a glance

  • Drugs Idursulfase (Primary) ; Immune globulin (Primary) ; Methotrexate (Primary) ; Rituximab (Primary)
  • Indications Mucopolysaccharidosis II
  • Focus Pharmacodynamics
  • Sponsors Takeda
  • Most Recent Events

    • 11 Dec 2024 Planned End Date changed from 15 Jun 2027 to 17 Jul 2028.
    • 11 Dec 2024 Planned primary completion date changed from 15 Jun 2027 to 17 Jul 2028.
    • 21 Sep 2023 Planned End Date changed from 9 Sep 2026 to 15 Jun 2027.

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