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Phase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy

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Trial Profile

Phase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 22 Jul 2024

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At a glance

  • Drugs Romiplostim (Primary)
  • Indications Aplastic anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Kyowa Kirin

Most Recent Events

  • 25 Sep 2023 According to a Kyowa Kirin International media release, the company has received approval from the Japanese Ministry of Health, Labour and Welfare for hematopoietic stimulating agent Romiplate, to change the approved indication from "aplastic anemia (AA) in patients who had an inadequate response to conventional therapy" to "AA" in Japan.
  • 01 Jan 2021 Status changed from active, no longer recruiting to completed, according to Results published in the British Journal of Haematology.
  • 18 Jun 2019 According to a Kyowa Hakko Kirin media release, the company announced that it has received the partial change approval of Romiplate for an additional indication of treatment of aplastic anemia (AA) in patients who have had an inadequate response to conventional therapy from Japan's Ministry of Health, Labour and Welfare (MHLW).

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