NCT06809972 Synovial Proliferation on Routine Ultrasound: Active or Inactive?
| NCT ID | NCT06809972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Van Creveldkliniek |
| Condition | Haemophilia |
| Study Type | OBSERVATIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 46 participants in total. It began in 2025-06-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There is cumulating evidence for the presence of non-observed or subclinical joint bleeding in patients with haemophilia. Early detection of active subclinical synovial proliferation would allow early intervention in order to prevent deterioration of joint health. Patients with subclinical (=non-observed) signs of synovial proliferation in knee(s), ankle(s) and/or elbow(s) will be invited to participate in this study to further characterize the synovial proliferation status (active or inactive) by means of physical examination, MRI, ultrasound and elastography. Synovial proliferation status will be monitored for a maximum period of 12 weeks, during which participants will also receive standard-of-care treatment, i.e. administration of optimized coagulation factor replacement therapy and prescription of the NSAID celecoxib (optional).
Eligibility Criteria
Inclusion Criteria: * Gender: male * Patients with severe haemophilia A or B * Treated with registered prophylaxis medication including coagulation factors and by- passing agents. * Age ≥ 12 years * Subclinical synovial proliferation in ≥1 joint (ankle, knee and/or elbow), defined as the presence of hypertrophic synovium, score \>0 according to the HEAD-US protocol, as confirmed during routine ultrasound screening. * Able to give written informed consent. Exclusion Criteria: * A major bleed ≤ 3 months or a minor bleed ≤ 1 month prior to inclusion in the joint of interest. * On demand therapy. * Currently treated with any type of haemophilia prophylaxis medication. * Joints with prosthesis or treated with arthrodesis will not be included for physical examination and ultrasound analysis. However, participants may still be included in the study with their other joints. * Confirmed inflammatory joint diseases such as rheumatoid arthritis or psoriatic arthritis. * History of inhibitor development (≥ 5 Bethesda Units\* (BU) at any time or 1-5 BU for * 1 year prior to inclusion. * Contra-indication for treatment with NSAIDs, (allergy, severe liver failure, renal failure (GFR \<30ml/min), congestive heart failure (NYHA II-IV), peripheral arterial disease and/or cerebrovascular disease.
Contact & Investigator
Lize van Vulpen, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Utrecht - Van Creveldkliniek
Frequently Asked Questions
Who can join the NCT06809972 clinical trial?
This trial is open to male participants only, aged 12 Years or older, studying Haemophilia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06809972 currently recruiting?
Yes, NCT06809972 is actively recruiting participants. Contact the research team at l.f.d.vanvulpen-2@umcutrecht.nl for enrollment information.
Where is the NCT06809972 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT06809972 clinical trial?
NCT06809972 is sponsored by Van Creveldkliniek. The principal investigator is Lize van Vulpen, MD, PhD at University Medical Center Utrecht - Van Creveldkliniek. The trial plans to enroll 46 participants.