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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

Trial Profile

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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 14 Feb 2019

At a glance

  • Drugs SB-BCLmR-HSPC (Primary) ; Busulfan; Plerixafor
  • Indications Sickle cell anaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Bioverativ
  • Most Recent Events

    • 08 Jan 2019 Planned End Date changed from 1 Sep 2022 to 1 Mar 2022.
    • 08 Jan 2019 Planned primary completion date changed from 1 Sep 2022 to 1 Mar 2022.
    • 08 Jan 2019 Status changed from not yet recruiting to recruiting.
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