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: 27 Jul 2017
At a glance
- Drugs Burosumab (Primary)
- Indications X-linked dominant hypophosphataemic rickets
- Focus Registrational; Therapeutic Use
- Sponsors Ultragenyx Pharmaceutical
- 27 Jul 2017 According to an Ultragenyx media release, the FDA agreed to accept any available bone biopsy data from this study as a supportive evidence for the Biologics License Application submitted to US FDA and the company plans to include the data from the first two patients in the BLA.
- 10 Jun 2017 Biomarkers information updated
- 25 May 2017 This trial was completed in Denmark, according to European Clinical Trials Database.