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A Randomized, Open-Label, Phase 3 Study to Assess the Efficacy and Safety of KRN23 Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients with X-linked Hypophosphatemia (XLH)

Trial Profile

A Randomized, Open-Label, Phase 3 Study to Assess the Efficacy and Safety of KRN23 Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients with X-linked Hypophosphatemia (XLH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2021

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At a glance

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

    • 01 Jul 2021 Results assessing the reliability, validity, and sensitivity to change of the RGI-C were evaluated using data from two studies (NCT02163577, NCT02915705) in pediatric XLH published in the Bone
    • 23 Jan 2020 Biomarkers information updated
    • 30 Sep 2019 According to an Ultragenyx Pharmaceutical media release, the indication has also been expanded to include infants as young as six months of age.For the pediatric XLH population, the U.S. label update is based on 64-week efficacy and safety data from this phase III study (as of 30th Sep 2019).
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