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A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism

Trial Profile

A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 30 Aug 2022

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At a glance

  • Drugs Parathyroid hormone (Primary)
  • Indications Hypoparathyroidism
  • Focus Therapeutic Use
  • Sponsors Shire; Takeda
  • Most Recent Events

    • 26 Aug 2022 Results (n=248) assessing the changes in estimated glomerular filtration rate over a 5-year period in adult patients with chronic hypoparathyroidism treated with recombinant parathyroid hormone (1-84), rhPTH(1-84), compared with a historical control cohort of patients who did not receive rhPTH(1-84) from REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309), and HEXT (NCT01199614 and continuation study NCT02910466) studies, published in the Advances in Therapy.
    • 20 May 2020 Status changed from active, no longer recruiting to completed.
    • 03 May 2019 Planned End Date changed from 30 Jul 2021 to 18 Jun 2021.
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