A Randomized, Open-Label, Dose Finding, Phase 2 Study to Assess the Pharmacodynamics and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Patients With X-linked Hypophosphatemia (XLH)
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 22 Mar 2018
At a glance
- Drugs Burosumab (Primary)
- Indications X-linked dominant hypophosphataemic rickets
- Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
- Sponsors Ultragenyx Pharmaceutical
- 16 Mar 2018 Planned End Date changed from 1 Dec 2018 to 30 Sep 2018.
- 23 Feb 2018 According to a Kyowa Kirin International media release, the European Commission has approved conditional marketing authorization of Crysvita (burosumab) for the treatment of X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
- 20 Feb 2018 According to a an Ultragenyx Pharmaceutical, a final decision on the conditional marketing authorization from the European Commission (EC) is expected in February 2018.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History