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A Phase 1/2, Open-Label, Multicenter, Single-Arm Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease

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A Phase 1/2, Open-Label, Multicenter, Single-Arm Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 Nov 2023

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At a glance

  • Drugs ST 400 (Primary) ; Busulfan; Plerixafor
  • Indications Sickle cell anaemia
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Acronyms PRECIZN-1
  • Sponsors Bioverativ

    • Most Recent Events

    • 17 Nov 2023 Planned End Date changed from 9 Aug 2024 to 14 Jul 2025.
    • 17 Nov 2023 Planned primary completion date changed from 9 Aug 2024 to 14 Jul 2025.
    • 17 Nov 2023 Status changed from recruiting to active, no longer recruiting.

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