Status:
COMPLETED
Intensive Replacement Treatment in Haemophilia Patients With Synovitis
Lead Sponsor:
Federico II University
Conditions:
Hemophilia A
Eligibility:
MALE
12-70 years
Phase:
PHASE4
Brief Summary
Background: Joint haemorrhage represents the most common type of bleeding episode in persons with hemophilia (PwH). In the absence of an adequate prophylaxis with Factor VIII (for hemophilia A) or FIX...
Detailed Description
Joint haemorrhage represents the most common type of bleeding episode in persons with hemophilia (PwH) and recurrent hemarthrosis triggers chronic arthropathy, which is the most frequent chronic compl...
Eligibility Criteria
Inclusion
- Male patients with \> 12 years of age, with severe (FVIII \< 1%) or severe-moderate (FVIII \< 2%) haemophilia A without inhibitors, receiving a prophylactic treatment with FVIII.
- Evidence at ultrasound evaluation of synovitis (grade 1-2 according to HEAD-US score)
- Signed and dated informed consent form for data collection prior to enrolment.
Exclusion
- Patients with bleeding disorders other than haemophilia A
- Patients with anti-FVIII inhibitor (any titer).
- Patients receiving on-demand treatment with FVIII
- Patients with liver cirrhosis
- Any condition that compromises the patient's ability to perform study-related activities or that poses a clinical contraindication to study participation.
- Patients unwilling or unable to follow the terms of the protocol.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04784988
Start Date
March 1 2022
End Date
March 1 2024
Last Update
March 27 2024
Active Locations (1)
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1
Matteo Di Minno
Napoli, Italy, 80131