2025-523896-44-00招募中3 期
Efanesoctocog alfa treatment in patients with synovitis in congenital hemophilia A: multicenter, randomized, open-label, phase 3 clinical trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- GWT-Tud GmbH
- 入组人数
- 60
- 试验地点
- 15
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
ALTUVOCT 500 IU powder and solvent for solution for injection, ALTUVOCT 250 IU powder and solvent for solution for injection, ALTUVOCT 1 000 IU powder and solvent for solution for injection, ALTUVOCT 3 000 IU powder and solvent for solution for injection, ALTUVOCT 2 000 IU powder and solvent for solution for injection
Test
干预措施: ALTUVOCT 500 IU powder and solvent for solution for injection (Drug)
ALTUVOCT 500 IU powder and solvent for solution for injection, ALTUVOCT 250 IU powder and solvent for solution for injection, ALTUVOCT 1 000 IU powder and solvent for solution for injection, ALTUVOCT 3 000 IU powder and solvent for solution for injection, ALTUVOCT 2 000 IU powder and solvent for solution for injection
Test
干预措施: ALTUVOCT 250 IU powder and solvent for solution for injection (Drug)
ALTUVOCT 500 IU powder and solvent for solution for injection, ALTUVOCT 250 IU powder and solvent for solution for injection, ALTUVOCT 1 000 IU powder and solvent for solution for injection, ALTUVOCT 3 000 IU powder and solvent for solution for injection, ALTUVOCT 2 000 IU powder and solvent for solution for injection
Test
干预措施: ALTUVOCT 1 000 IU powder and solvent for solution for injection (Drug)
ALTUVOCT 500 IU powder and solvent for solution for injection, ALTUVOCT 250 IU powder and solvent for solution for injection, ALTUVOCT 1 000 IU powder and solvent for solution for injection, ALTUVOCT 3 000 IU powder and solvent for solution for injection, ALTUVOCT 2 000 IU powder and solvent for solution for injection
Test
干预措施: ALTUVOCT 3 000 IU powder and solvent for solution for injection (Drug)
ALTUVOCT 500 IU powder and solvent for solution for injection, ALTUVOCT 250 IU powder and solvent for solution for injection, ALTUVOCT 1 000 IU powder and solvent for solution for injection, ALTUVOCT 3 000 IU powder and solvent for solution for injection, ALTUVOCT 2 000 IU powder and solvent for solution for injection
Test
干预措施: ALTUVOCT 2 000 IU powder and solvent for solution for injection (Drug)
研究者
FB Medizin
Scientific
GWT-Tud GmbH
研究点 (15)
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