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Efanesoctocog alfa treatment in patients with congenital hemophilia A suffering from inflammation of joint lining
EU CTIS ID: 2025-523896-44-00
What this study is testing
The primary objective of the study is to assess the efficacy of Efanesoctocog alfa intensified replacement therapy (ERT) to reduce or resolve signs of synovitis in patients with congenital hemophilia A.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent must be obtained before any study-specific tests or procedures are performed
- Male patients aged between 18 and 70 years at the first screening visit
- Patients must be capable of giving informed consent and have the ability to understand and follow study-related instructions
- Patients with severe to moderate congenital hemophilia A
- Regular prophylaxis with licensed FVIII products (SHL-FVIII, EHL-FVIII or HS-FVIII) at its recommended regimen during the last 6 months
- Synovitis of elbow, knee, and/or ankle joint (score ≥ 1 for synovial hypertrophy in HEAD-US) confirmed by Blinded ultrasound examination (BLUE) at the time of screening
You likely can't join if
- Acute hemarthrosis at time of screening (clinical or ultrasound detected) or within the past 4 weeks before screening (clinical)
- Use of anticoagulant or antiplatelet drugs at the time of screening
- Known bleeding disorder other than hemophilia A
- Life expectancy <12 months at the time of screening
- Hypersensitivity to the active substance or to any of the excipients of the IMP
- Patients of Asian ethnicity
See the full eligibility criteria
- Written informed consent must be obtained before any study-specific tests or procedures are performed
- Male patients aged between 18 and 70 years at the first screening visit
- Patients must be capable of giving informed consent and have the ability to understand and follow study-related instructions
- Patients with severe to moderate congenital hemophilia A
- Regular prophylaxis with licensed FVIII products (SHL-FVIII, EHL-FVIII or HS-FVIII) at its recommended regimen during the last 6 months
- Synovitis of elbow, knee, and/or ankle joint (score ≥ 1 for synovial hypertrophy in HEAD-US) confirmed by Blinded ultrasound examination (BLUE) at the time of screening
- Acute hemarthrosis at time of screening (clinical or ultrasound detected) or within the past 4 weeks before screening (clinical)
- Use of anticoagulant or antiplatelet drugs at the time of screening
- Known bleeding disorder other than hemophilia A
- Life expectancy <12 months at the time of screening
- Hypersensitivity to the active substance or to any of the excipients of the IMP
- Patients of Asian ethnicity
- Close affiliation with the investigator (e.g. a close relative) or persons working at the study site, the sponsor or involved CRO
- Participation in another clinical interventional trial in the 3 months before screening
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety
- Patient is in custody by virtue of an order issued either by the judicial or the administrative authorities
- Current factor VIII inhibitor ≥0.6 BU/mL
- Current immune tolerance therapy
- Planned intensification of FVIII prophylaxis above the allowed doses specified in the protocol (Table 1, section 5.1)
- Radiosynovectomy (RSO) or orthopedic surgery during the past 3 months or planned within the next 12 months
- History of thrombosis, myocardial infarction, other clinically relevant vascular diseases, or atrial fibrillation, or combination of risk factors that would significantly increase the cardiovascular risk during ERT or standard of care (SOC)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.