NCT07390240 The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia
| NCT ID | NCT07390240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Hypophosphatasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2025-12-29 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2025-12-29 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The effect of monoallelic variants in the ALPL gene on the natural course of hypophosphatasia (HPP) in children and adults in Russia (ATLANTIS)
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07390240 clinical trial?
This trial is open to participants of all sexes, studying Hypophosphatasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07390240 currently recruiting?
Yes, NCT07390240 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07390240 trial being conducted?
This trial is being conducted at Moscow, Russia, Moscow, Russia, Rostov-on-Don, Russia, Saint Petersburg, Russia.
Who is sponsoring the NCT07390240 clinical trial?
NCT07390240 is sponsored by AstraZeneca. The trial plans to enroll 55 participants.