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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT05890794
Eligibility Criteria:
Inclusion Criteria:
* Genetically confirmed variant in the tissue-nonspecific isozyme alkaline phosphatase (ALPL)-Gene.
* Clinical symptoms of HPP.
* Medical history with 1) at least two independent measures of Alkaline Phosphatase (ALP) below lower level of normal (LLN) and 2) at least one measurement of either PPi or PLP above upper level of normal (ULN).
* Provision of signed and dated informed consent form (ICF) in accordance with local regulations at screening.
* Patients must agree not to get pregnant/not to get their partner pregnant, during the trial. Consequently, patients must agree to use adequate contraception as detailed in study protocol.
Exclusion Criteria:
* Participant is unable or unwilling to participate in all scheduled visits and perform all protocol-mandated assessments.
* Has a known or suspected hypersensitivity to ilofotase alfa or any components of the formulation used.
* Body weight \< 40 kilogram and \> 120 kilogram.
* Patient has a history of clinically significant abnormalities or of any illness that, in the opinion of the trial investigator, might confound the results of the trial or pose an additional risk to the patient by their participation in the trial.
* NSAID use in the past 2 weeks.
* Use of corticosteroids in the past 4 weeks.
* Use of compounds intended to interfere with bone metabolism (e.g. Denosumab, Teriparatide, Romosozumab, Raloxifene) in the past 3 months.
* Use of bisphosphonates in the past 2 years.
* Participation in a drug trial within 60 days, or five times the half-life of the drug, whichever is longer, prior to administration of ilofotase alfa.
* Use of asfotase alfa in the previous 3 months. Patients will not be withheld from approved asfotase alfa if medically indicated.
* A patient who is currently pregnant or lactating.
* Use of supplements including Vitamin B6.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05890794
Study Brief:
Protocol Section:
NCT05890794