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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03651505
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide informed consent or, in the case of patients under the age of 18 years (or 16 years, depending on the region), provide assent (if required) and informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Clinical diagnosis of XLH based on family history, OR confirmed PHEX mutation, OR biochemical profile consistent with XLH.
* Willing and able to comply with the study visit schedule and study procedures.
Exclusion Criteria:
* Concurrent enrollment in an Ultragenyx-sponsored clinical trial is NOT permitted.
* Serious medical or psychiatric comorbidity.
* Less than one year of life expectancy.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03651505
Study Brief:
Protocol Section:
NCT03651505