X-linked hypophosphatemia
Conditions
Interventions
None listed
Sponsors
Heydorn Arne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent obtained before any trial-related activities, i.e., any procedure related to recording of data according to the protocol. - Male or female and aged 18-64 years (both inclusive) at the time of signing informed consent. - Diagnosis of congenital X-linked hypophosphatemia (XLH), confirmed genetically or clinically as determined by the investigator, supported by documentation. - Participants have been treated with burosumab for at least 90 days prior to the screening/baseline visit and treatment is still ongoing. - Participant confirms ability and willingness to attend visits according to routine clinical care and mandatory assessments at the site.
Exclusion criteria
Exclusion criteria: - Previous rescreening for this trial. - Current participation in any interventional clinical trial. Participation in another non-interventional trial, such as a patient registry trial, is permitted. - Any condition not associated with XLH, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average trough serum phosphate concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Endpoints: - Average midpoint serum phosphate concentration - Average (both trough and midpoint) serum phosphate concentration - Trough serum phosphate levels over time - Midpoint serum phosphate levels over time - Midpoint-trough difference of serum phosphate levels over time | — |
Countries
Australia, Canada, France, Germany, Italy, Japan, Netherlands, United States
Contacts
Public Contactcontact Clinical study
ICON Clinical Research GK
Outcome results
None listed