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The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia | Clinical Trials | Clareo Health

RECRUITING

The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia

The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia (HPP) in Children and Adults in Russia

NCT07390240•AstraZeneca

View on ClinicalTrials.gov

Summary

The effect of monoallelic variants in the ALPL gene on the natural course of hypophosphatasia (HPP) in children and adults in Russia (ATLANTIS)

Detailed Description

Non-interventional, multi-center, cohort study for evaluation of clinical and patient reported outcomes in routine care settings

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥4 to \<18 years, or ≥18 years at the time of enrollment;
•2. Signed ICF for patients ≥18 years, or legal representatives (parents) of patients aged ≥4 to \<18 years;
•3. Written informed assent (for patients aged ≥14 to \<18 years only);
•4. No history of HPP treatment with enzyme-replacement therapy;
•5. Diagnosis of HPP confirmed by:
•* reduced alkaline phosphatase (ALP) activity relative to age- and sex-specific reference ranges, confirmed by at least two separate measurements, AND
•* the identification of a monoallelic pathogenic, likely pathogenic, or variant of uncertain significance in the ALPL gene on genetic testing.

Exclusion Criteria

•1. Confirmed conditions presenting with clinical features overlapping with HPP, including but not limited to: cerebral palsy, Duchenne muscular dystrophy, limb-girdle muscular dystrophy (Erb-Roth dystrophy), acquired secondary myopathies of various etiologies;
•2. Сurrent participation in any clinical study (patients participating in other non interventional studies may be included);
•3. Homozygous or compound heterozygous mutation in the ALPL gene
•4. In the opinion of the investigator, the patient is not able to return for follow-up visits or obtain required follow-up studies.
•5. Pregnant and breastfeeding women.

Locations (2)

Research site

Moscow, Russia

Research site

Saint Petersburg, Russia

Key Dates

Start Date

December 29, 2025

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2027

Last Updated

March 6, 2026

Enrollment

ESTIMATED participants

Conditions

Hypophosphatasia

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

A Prospective Sub-Study of the Global Hypophosphatasia Registry

NCT05234567

Hypophosphatasia

View study

RECRUITINGPHASE1/PHASE2

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALE1 in Healthy Adults and Adults With Hypophosphatasia in Order to Identify Suitable Doses of ALE1

NCT07179640

Hypophosphatasia (HPP)

View study

ACTIVE_NOT_RECRUITINGPHASE3

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia

Inclusion Criteria

Exclusion Criteria

A Prospective Sub-Study of the Global Hypophosphatasia Registry

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALE1 in Healthy Adults and Adults With Hypophosphatasia in Order to Identify Suitable Doses of ALE1

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia

Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)

Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)