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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02531867
Eligibility Criteria:
Inclusion Criteria:
1. Patient or parent (or legal guardian) must provide written informed consent prior to the performance of any study-related procedures and must be willing to comply with study procedures. Where appropriate and required by local regulations, patient assent for participation must also be obtained.
2. Patient has completed the investigator-initiated clinical study (HPPJEAP-01) protocol for asfotase alfa
Exclusion Criteria:
1. Patient has a documented form of rickets caused by a condition other than HPP, including, but not limited to, rickets caused by 25(OH) vitamin D deficiency
2. Patient has serum calcium and/or phosphorus levels below the normal range
3. Patient is pregnant or lactating
4. Patient received treatment with bisphosphonates within 2 years prior to the Screening visit
5. Patient has a documented sensitivity to any of the components of asfotase alfa
6. Patient is currently enrolled in any other program or clinical study involving an investigational new drug, device, or treatment for HPP (eg, bone marrow transplantation)
7. Patient has clinically significant other disease in the opinion of the Investigator, defined as any other non HPP-related condition for which the patient is considered medically unstable.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02531867
Study Brief:
Protocol Section:
NCT02531867