An Open-Label, Phase 2 Study to Assess the Safety, Pharmacodynamics, and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)

Trial Profile

An Open-Label, Phase 2 Study to Assess the Safety, Pharmacodynamics, and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Apr 2018

At a glance

  • Drugs Burosumab (Primary)
  • Indications X-linked dominant hypophosphataemic rickets
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • 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 pediatric patients one year of age and older, based on the data from this study.
    • 20 Mar 2018 Result of combined efficacy and safety data of every 2-week dosing through week 40 from two studies (NCT02163577 and NCT02750618) presented at The 100th Annual Meeting of the Endocrine Society
    • 20 Mar 2018 Planned End Date changed from 1 Oct 2019 to 16 Aug 2019.
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