Status:
ACTIVE_NOT_RECRUITING
A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Hemophilia A
Eligibility:
All Genders
Brief Summary
This is a 48-month observational, prospective, multicentre study. The overall aim of the study is to evaluate the long-term effectiveness of Elocta treatment on joint health in patients treated prophy...
Detailed Description
Haemophilia A is a rare genetic disorder estimated to occur in one out of 10,000 live births, characterized by a deficiency in coagulation factor VIII causing impaired haemostasis and prolonged bleedi...
Eligibility Criteria
Inclusion
- Provided signed and dated informed consent by the patient, or the patient's legally authorized representative(s) for patients under the legal age, before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations
- Have a diagnosis of haemophilia A
- At enrolment on prophylactic treatment with Elocta, independent of participation in the study
Exclusion
- Enrolment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product (IMP), within three months prior to inclusion in this study
- Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit \[BU\]/mL) at the latest available inhibitor test
Key Trial Info
Start Date :
March 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT04293523
Start Date
March 30 2020
End Date
April 1 2026
Last Update
January 22 2025
Active Locations (53)
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1
University Hospital Brno
Brno, Czechia
2
University Hospital Ostrava
Ostrava, Czechia
3
Dept. of Pediatric Haematology and Oncology, University Hospital Motol
Prague, Czechia
4
Lastehaigla, Tallinn (Tallinn Children´s Hospital)
Tallinn, Estonia