Actively Recruiting

All Genders
NCT05234567

A Prospective Sub-Study of the Global Hypophosphatasia Registry

Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-02-09

30

Participants Needed

12

Research Sites

307 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Prospective Sub-Study of the Global Hypophosphatasia Registry

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Any age or sex with a confirmed diagnosis of pediatric-onset HPP (first sign or symptom before 18 years old)
  • Currently receiving asfotase alfa treatment at enrollment or physician has decided to resume or start asfotase alfa treatment within 6 months after enrollment
  • Documented low alkaline phosphatase (ALP) activity below normal for age and sex
  • Documented ALPL gene mutation, or for infants needing immediate treatment, documentation within 6 months after enrollment
  • Ability of participant or parent/legal representative to read and understand informed consent and study questionnaires in local language
  • Willingness and ability of participant or parent/legal representative to give signed informed consent, and participant willing to give written assent if required
Not Eligible

You will not qualify if you...

  • Currently participating in an Alexion-sponsored interventional clinical study. Participants who have completed such studies are eligible.

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Clinical Trial Site

Hartford, Connecticut, United States, 06106

Actively Recruiting

2

Clinical Trial Site

Chicago, Illinois, United States, 60611

Actively Recruiting

3

Clinical Trial Site

Boston, Massachusetts, United States, 02122

Actively Recruiting

4

Clinical Trial Site

Kansas City, Missouri, United States, 64108

Actively Recruiting

5

Clinical Trial Site

Mineola, New York, United States, 11501

Actively Recruiting

6

Clinical Trial Site

Cincinnati, Ohio, United States, 45229

Not Yet Recruiting

7

Clinical Trial Site

Columbus, Ohio, United States, 43203

Actively Recruiting

8

Clinical Trial Site

Pittsburgh, Pennsylvania, United States, 15224

Not Yet Recruiting

9

Clinical Trial Site

Nashville, Tennessee, United States, 37112

Actively Recruiting

10

Clinical Trial Site

Salt Lake City, Utah, United States, 84108

Actively Recruiting

11

Clinical Trial Site

Charlottesville, Virginia, United States, 22903

Actively Recruiting

12

Clinical Trial Site

Madison, Wisconsin, United States, 53792

Actively Recruiting

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Research Team

A

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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