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)
Phase of Trial: Phase II
Latest Information Update: 12 Jul 2019
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At a glance
- Drugs Burosumab (Primary)
- Indications X-linked dominant hypophosphataemic rickets
- Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
- Sponsors Ultragenyx Pharmaceutical
- 06 Dec 2018 According to an Ultragenyx Pharmaceutical media release, Crysvita is now approved in the United States, Europe and Canada, all within one year, and Ultragenyx and Kyowa Kirin are pursuing regulatory filings in other countries to ensure that Crysvita is available to patients with XLH around the world as quickly as possible.
- 06 Dec 2018 According to an Ultragenyx Pharmaceutical media release, the Health Canada has approved Crysvita for the treatment of XLH in adult and pediatric patients one year of age and older.The Health Canadas approval for the pediatric XLH population is supported by the 64-week data from this Study CL201 and 40-week data from Study CL205.
- 05 Nov 2018 Status changed from active, no longer recruiting to completed.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History