The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia
Recruiting now
Conditions studied: Hypophosphatasia
In brief
The effect of monoallelic variants in the ALPL gene on the natural course of hypophosphatasia (HPP) in children and adults in Russia (ATLANTIS)
Key facts
- Study ID
- NCT07390240
- Run by
- AstraZeneca
- People needed
- 55
- Starts
- 2025-12-29
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-07-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥4 to <18 years, or ≥18 years at the time of enrollment;
- Signed ICF for patients ≥18 years, or legal representatives (parents) of patients aged ≥4 to <18 years;
- Written informed assent (for patients aged ≥14 to <18 years only);
- No history of HPP treatment with enzyme-replacement therapy;
- 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.
You may not qualify if…
- 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;
- Сurrent participation in any clinical study (patients participating in other non interventional studies may be included);
- Homozygous or compound heterozygous mutation in the ALPL gene
- In the opinion of the investigator, the patient is not able to return for follow-up visits or obtain required follow-up studies.
- Pregnant and breastfeeding women.
Where it is running
- Research Site — Moscow, Russia (enrolling)
- Research Site — Rostov-on-Don, Russia (enrolling)
- Research site — Saint Petersburg, Russia (enrolling)
- Research site — Moscow, Russia
Full record on ClinicalTrials.gov
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