Status:
COMPLETED
A UK Multicentre, Health-Related Quality of Life Study for Children and Adolescents With XLH
Lead Sponsor:
Kyowa Kirin Pharmaceutical Development Ltd
Conditions:
X-Linked Hypophosphataemia
Eligibility:
All Genders
4-18 years
Brief Summary
This study aims to provide Health-related Quality of Life (HRQoL) data from children and adolescents with growing skeletons in the United Kingdom (UK), including those treated with burosumab or altern...
Detailed Description
This is a multicentre, non-interventional HRQoL study of children and adolescents with growing skeletons using routinely collected XLH Registry data and prospectively collected HRQoL data. This study ...
Eligibility Criteria
Inclusion
- Aged ≥4 years and \<18 years.
- Enrolled in the XLH Registry via one of the participating UK centres.
- Have at least one of the following:
- RSS calculated at enrolment during a routine clinic visit. OR
- Historical radiographs of the affected wrist and/or knee available in the medical chart within the 6 months prior to enrolment, to allow RSS to be centrally calculated retrospectively.
- Receiving any XLH treatment (burosumab, oral phosphate and active vitamin D, or other XLH treatment) within 30 days prior to informed consent for this study
Exclusion
- Does not have the cognitive capacity to provide informed consent, or their legally designated representative (i.e. parent / legal guardian) does not have the cognitive capacity to provide informed consent.
- Is not expected to have open growth plates for the duration of the study.
- Currently participating in an interventional clinical trial. Participation in a Compassionate Use Programme, Pre-commercial Programme, or Investigator Initiated Study does not preclude a patient from participation in this study.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04819490
Start Date
April 1 2021
End Date
July 29 2022
Last Update
July 25 2024
Active Locations (6)
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1
Royal Hospital for Sick Children
Edinburgh, United Kingdom, EH9 1LF
2
NHS Greater Glasgow & Clyde- South Glasgow University Hosp Division
Glasgow, United Kingdom, G12 0XH
3
Leeds Teaching Hospitals NHS Trust, Trust Headquarters, St. James's University Hospital
Leeds, United Kingdom, LS9 7TF
4
Evelina Childrens Hospital
London, United Kingdom, SE1 7EH