X-linked Hypophosphatemia Disease Monitoring Program

Status Active, not recruiting

Clinical Trial Summary

The objectives of this observational study are to characterize XLH disease presentation and progression and to assess long-term effectiveness and safety of burosumab.

Clinical Trial Description

The XLH-DMP is a global, prospective, multicenter, longitudinal, long-term outcomes program for subjects on or off any treatment designed to characterize XLH disease presentation and progression, assess long-term safety and effectiveness of burosumab, as well as prospectively investigate longitudinal change over time across biomarker(s), clinical assessments, and patient/caregiver-reported outcome measures in a representative population. The XLH-DMP will collect demographic, biochemical, physiologic, disease severity, and progression data in patients taking burosumab and those not taking burosumab. In this DMP, patients will only have access to burosumab through authorized prescribed use. The Sponsor will not provide any treatments as part of the DMP. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03651505
Study type	Observational
Source	Ultragenyx Pharmaceutical Inc
Contact
Status	Active, not recruiting
Phase
Start date	July 16, 2018
Completion date	December 2032

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02915705` - Efficacy and Safety of Burosumab (KRN23) Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With X Linked Hypophosphatemia (XLH)	Phase 3
Recruiting	`NCT03879915` - Dental Implants in Patients With X-linked Hypophosphatemia
Active, not recruiting	`NCT03193476` - Registry for Patients With X-Linked Hypophosphatemia
Completed	`NCT02526160` - Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)	Phase 3
Completed	`NCT05181839` - A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth
Completed	`NCT04146935` - Examining the Effect of Burosumab on Muscle Function	Phase 4
Completed	`NCT02750618` - Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)	Phase 2
Active, not recruiting	`NCT03745521` - Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners
Completed	`NCT03920072` - Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH	Phase 3
Recruiting	`NCT03748966` - Calcitriol Monotherapy for X-Linked Hypophosphatemia	Early Phase 1
Recruiting	`NCT04419363` - Burosumab in Children and Adolescents With X-linked Hypophosphatemia	Phase 4
Completed	`NCT02163577` - Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)	Phase 2
Completed	`NCT06067932` - Foot Disorders in X-linked Hypophosphatemia
Completed	`NCT04695860` - Anti-FGF23 (Burosumab) in Adult Patients With XLH	Phase 3
Completed	`NCT02312687` - Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)	Phase 2
Completed	`NCT03596554` - X-linked Hypophosphatemia and FGF21
Recruiting	`NCT03820518` - Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia	Phase 4
Completed	`NCT01571596` - An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia	Phase 1/Phase 2
Completed	`NCT04273490` - Characterising Pain, QoL, Body Composition, Arterial Stiffness, Muscles and Bones in Adult Persons With XLH and Healthy Controls
Completed	`NCT03489993` - FGF23 and Angiotensin-(1-7) in Hypophosphatemia (GAP)