Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03771105
Eligibility Criteria:
Inclusion Criteria:
* Children above the age of 13 years
* Younger and older adults with XLH and HHRH with confirmed NPT2c mutations affecting both copies of the NPT2c gene (HHRH) or one copy of the PHEX gene (XLH)
* Be willing to provide access to prior medical records to determine eligibility including imaging, biochemical, medical, and surgical history data
* Be willing and able to complete all aspects of the study
* Be willing to adhere to the study visit schedule and comply with the assessments (in the opinion of the investigator).
Exclusion Criteria:
* Subjects will be excluded, if they are children younger than age 13 years
* Subjects that have other diseases likely to impact bone and mineral metabolism (e.g. renal, hepatic, gastrointestinal disorders, and malignancy),
* Subjects that are currently pregnant,
* Subjects that received medical therapy or developed any condition, which in the opinion of the investigator, could present a concern for either subject safety or difficulty with data interpretation.
* Subjects will be excluded from Aim 2, if they are unable to tolerate supplemental phosphate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT03771105
Study Brief:
Protocol Section:
NCT03771105