Status:
ENROLLING_BY_INVITATION
Efficacy and Safety of Enzyme Replacement Therapy in Patients With Fabry Disease
Lead Sponsor:
NPO Petrovax
Conditions:
Fabry Disease
Eligibility:
All Genders
8-65 years
Brief Summary
The goal of this observational study is to learn how enzyme replacement therapy works in patients with Fabry disease. The main question it aims to answer is: What medical problems do participants hav...
Detailed Description
All patients on enzyme replacement therapy could be enrolled in the study. Three medicines are currently available in Russia (Fabagal®, Fabrazyme®, Replagal®) so the patients form three cohorts. For ...
Eligibility Criteria
Inclusion
- Men and women with a confirmed diagnosis of Fabry disease;
- Prescribed course of enzyme replacement therapy with any drug (Fabagal, Fabrazyme, Replagal);
- Age 8 - 65 years;
- Signed informed consent of the patient and/or patient's legal representative for participation in the study and processing of personal data.
Exclusion
- Renal replacement therapy or kidney transplantation;
- Critical illness unrelated to Fabry disease;
- Pregnancy or breastfeeding;
- Refusal of the patient (or patient's legal representative) from further participation in the study or medical care.
Key Trial Info
Start Date :
March 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06880250
Start Date
March 24 2025
End Date
January 1 2027
Last Update
December 31 2025
Active Locations (23)
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1
#13
Astrakhan, Russia
2
#27
Barnaul, Russia
3
#7
Borovichi, Russia
4
#6
Chelyabinsk, Russia