RecruitingNCT05234567

A Prospective Sub-Study of the Global Hypophosphatasia Registry

A Prospective Observational Sub-Study of the Global Hypophosphatasia Registry to Describe the Potential Risk of Immune-Mediated Loss of Pharmacological Effect of Asfotase Alfa in Participants With Hypophosphatasia


Sponsor

Alexion Pharmaceuticals, Inc.

Enrollment

30 participants

Start Date

Aug 25, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

In this prospective observational sub-study, participants with pediatric-onset hypophosphatasia (HPP) (perinatal/infantile- or juvenile-onset) of any age will be followed for a minimum of 5 years at sites in the United States and potentially 1 or 2 other countries.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Asfotase Alfa for people with hypophosphatasia. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAsfotase Alfa

All participants will receive asfotase alfa subcutaneously per standard of care. Unless otherwise specified per the Physician's standard of care, participants aged \< 2 years are recommended for a clinic visit approximately every 3 months after Enrollment until 2 years of age, after which they should have a clinic visit approximately every 6 months. Participants should be followed for 5 years, as possible.


Locations(12)

Clinical Trial Site

Hartford, Connecticut, United States

Clinical Trial Site

Chicago, Illinois, United States

Clinical Trial Site

Boston, Massachusetts, United States

Clinical Trial Site

Kansas City, Missouri, United States

Clinical Trial Site

Mineola, New York, United States

Clinical Trial Site

Cincinnati, Ohio, United States

Clinical Trial Site

Columbus, Ohio, United States

Clinical Trial Site

Pittsburgh, Pennsylvania, United States

Clinical Trial Site

Nashville, Tennessee, United States

Clinical Trial Site

Salt Lake City, Utah, United States

Clinical Trial Site

Charlottesville, Virginia, United States

Clinical Trial Site

Madison, Wisconsin, United States

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NCT05234567


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