Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for kids with brittle bones: experimental drug faces off against standard care

NCT ID NCT06079372

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new medicine, ALXN1850, to the current standard treatment (asfotase alfa) in 43 children aged 2 to 12 with hypophosphatasia, a rare genetic condition that weakens bones. All children have been on the standard treatment for at least 6 months before joining. The main goal is to see if the new drug is safe and tolerable. Researchers will also check bone healing, rickets severity, and walking ability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

43 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of HPP documented in the medical records * Presence of open growth plates by X-ray during Screening Period * Tanner stage 2 or less during the Screening Period * Must have been treated with 6 mg/kg/ week of asfotase alfa via SC injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6 months before Day 1. Note: participants currently treated with 9 mg/kg (eg, 3 mg/kg 3 times per week) will not be allowed in the study. Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator. * Diagnosis of primary or secondary hyperparathyroidism * Hypoparathyroidism, unless secondary to HPP * Any new fracture within 12 weeks before Day 1 (excluding pseudofractures) * Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period * History of allergy or hypersensitivity to any ingredient contained in asfotase alfa or ALXN1850 * Body weight \< 10 kg during the Screening Period

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypophosphatasia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

hypophosphatasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypophosphatasia

Contacts and locations

Locations

  • Research Site

    Hartford, Connecticut, 06106, United States

  • Research Site

    Baltimore, Maryland, 21287, United States

  • Research Site

    Minneapolis, Minnesota, 55455, United States

  • Research Site

    Kansas City, Missouri, 64108, United States

  • Research Site

    Durham, North Carolina, 27705, United States

  • Research Site

    Nashville, Tennessee, 37212, United States

  • Research Site

    Mar del Plata, B7600, Argentina

  • Research Site

    South Brisbane, 4101, Australia

  • Research Site

    Ottawa, Ontario, K1H 8L1, Canada

  • Research Site

    Bunkyō City, 113-8431, Japan

  • Research Site

    Minatoku, 105-8471, Japan

  • Research Site

    Suita-shi, 565-0871, Japan

  • Research Site

    Yonago-shi, 683-8504, Japan

  • Research Site

    Altındağ, 06230, Turkey (Türkiye)

  • Research Site

    Ankara, 06560, Turkey (Türkiye)

  • Research Site

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    Erzurum, 25240, Turkey (Türkiye)

  • Research Site

    Istanbul, 34899, Turkey (Türkiye)

  • Research Site

    Birmingham, B4 6NH, United Kingdom

  • Research Site

    Manchester, United Kingdom

  • Research Site

    Sheffield, S10 2TH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.