Congenital hemophilia A
Conditions
Interventions
None listed
Sponsors
Ioka Akiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be included in the study if they meet all of the following items. 1) Patients with congenital haemophilia A (any age, male or female) who are undergoing regular bleeding prophylaxis including emicizumab or who are scheduled to start by the start of observation (Week 0 visit) 2) Patients who have received adequate explanation of the content of this study, and who have given written consent based on their own free will from the subjects of the study or their legally acceptable representative, and who are able to comply with the procedures of the study protocol.
Exclusion criteria
Exclusion criteria: Study subjects who fall under any of the following items will be excluded from the study: 1) Patients with concomitant systemic diseases (e.g., rheumatoid arthritis) with joint involvement 2) Patients with other bleeding disorders other than congenital hemophilia A 3) Patients who are judged by the research director or research co-workers at the participating medical organization to have a significant range of motion restriction or prosthesis in 4 or more of the 6 joints of the left and right foot, knee, and elbow. 4) Subjects whose MRI is judged to be difficult to perform by the study director or study co-workers 5) Patients with difficulties in using electronic patient-reported outcomes (electronic patient-reported outcome:ePRO) (patients or caregivers) 6) Patients who are participating in clinical research involving clinical trials or interventions (including planned participation) 7) Patients who are judged to be inappropriately participating in the study by the research director or research subinvestigator at the participating medical institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of fluid collection (joint fluid/blood), synovial thickening, cartilaginous degeneration, and bone degeneration based on the central assessment of US images (foot, knee, and elbow). | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of fluid retention, synovial thickening, cartilaginous degeneration, and bone degeneration based on the central assessment of MRI images (foot, knee, and elbow). | — |
Contacts
Public ContactTakahiro Ito
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed