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: 24 Nov 2017
At a glance
- Drugs Burosumab (Primary)
- Indications X-linked dominant hypophosphataemic rickets
- Focus Adverse reactions; Pharmacodynamics; Therapeutic Use
- Sponsors Ultragenyx Pharmaceutical
- 17 Nov 2017 Planned End Date changed from 1 Dec 2017 to 1 Oct 2019.
- 17 Nov 2017 Planned primary completion date changed from 30 Oct 2017 to 1 Oct 2019.
- 10 Oct 2017 The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for review of burosumab to treat pediatric and adult patients with X-Linked Hypophosphatemia (XLH) and has granted Priority Review status. The Prescription Drug User Fee Act (PDUFA) action date for the BLA is April 17, 2018.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History