An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH).

Trial Profile

An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH).

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Apr 2018

At a glance

  • Drugs Burosumab (Primary)
  • Indications X-linked dominant hypophosphataemic rickets
  • Focus Registrational; Therapeutic Use
  • Sponsors Ultragenyx Pharmaceutical
  • Most Recent Events

    • 17 Apr 2018 According to the Ultragenyx Pharmaceutical media release, The U.S. Food and Drug Administration (FDA) has approved Crysvita (burosumab-twza) for the treatment of X-linked hypophosphatemia (XLH) in adult patients and has granted priority review status, based on the data from this study.
    • 12 Feb 2018 Planned End Date changed from 1 Aug 2017 to 30 Sep 2018.
    • 02 Nov 2017 According to an Ultragenyx Pharmaceutical media release, 48 week data from the study is expected by the end of 2017.
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