Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT02253693
Eligibility Criteria:
Inclusion Criteria:
* Male patients over 18
* Patients diagnosed with haemophilia A and under prophylaxis treatment with the same FVIII for 2 years prior to the inclusion in the study.
* Patients with haemophilic arthropathy in, at least, one of the four load-bearing joints (knees and ankles), according to clinical and/or radiographic criteria (at least 3 in the Gilbert scale and /or at least 3 in the Pettersson scale) and/or Chronic synovitis evidenced by ultrasound.
* Patients with signed informed consent.
Exclusion Criteria:
* Patients who have developed an inhibitor antibody (≥5 Bethesda units), at the moment of the inclusion in the study.
* Development of inhibitors
* Modification, during follow-up, of FVIII with which the patient started the study.
* The patient decides to withdraw voluntarily from the study.
* Major orthopaedic surgery
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02253693
Study Brief:
Protocol Section:
NCT02253693