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An Observational Long-term Safety and Efficacy Follow-up Study After Ex-vivo Gene Therapy With BIVV003 in Participants With Severe Sickle Cell Disease (SCD) or With ST-400 in Participants With Transfusion-dependent Beta-thalassemia (TDT) With Autologous Hematopoietic Stem Cell Transplant

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An Observational Long-term Safety and Efficacy Follow-up Study After Ex-vivo Gene Therapy With BIVV003 in Participants With Severe Sickle Cell Disease (SCD) or With ST-400 in Participants With Transfusion-dependent Beta-thalassemia (TDT) With Autologous Hematopoietic Stem Cell Transplant

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 11 Jun 2024

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At a glance

  • Drugs ST 400 (Primary)
  • Indications Beta-thalassaemia; Sickle cell anaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Bioverativ; Sangamo Therapeutics

    • Most Recent Events

    • 05 Jun 2024 Planned End Date changed from 10 Aug 2037 to 14 Jul 2038.
    • 05 Jun 2024 Planned primary completion date changed from 10 Aug 2037 to 14 Jul 2038.
    • 14 Dec 2022 Planned number of patients changed from 13 to 12.

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