NCT07830732尚未招募3 期
A Multinational, Open-label Study to Investigate Efficacy and Safety of Denecimig (Mim8) in Adults With Acquired Haemophilia A
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 83
- 主要终点
- Number of treated bleeds
研究概览
简要总结
The purpose of this study is to find out if denecimig is safe and effective for treating people who have acquired haemophilia A. Participants will be in this study for up to around 1 year and 5 months (73 week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female participants (sex assigned at birth, inclusive of all gender identities) newly diagnosed with acquired haemophilia A (AHA) prior to signing the informed consent form, with AHA diagnosis (FVIII activity lesser than (<) 50 percentage (%) and FVIII inhibitors greater than (>) 0.6 Bethesda units [BU]) confirmed at screening.
- •Treatment-requiring bleed(s) due to AHA from diagnosis and until screening.
- •The participant is capable of following study procedures and able to seek medical attention when needed.
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method.
- •Previous or current thromboembolic disease or eventsa (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease.
- •Life expectancy <3 months at the time of screening, as evaluated by the investigator.
- •Therapy with immunosuppressive or immune modulating drugs for treatment of AHA (other than less than or equal to (≤) 2 days of prednisolone (or equivalent) for AHA at a dose ≤100 mg per day) prior to screening.
- •Immunosuppressive therapy (IST) initiated prior to AHA diagnosis for other medical conditions (e.g., other autoimmune disorders) is permitted, provided it was initiated greater than or equal to (≥) 6 months prior to screening, has been maintained at a stable dose and regimen since initiation, and is expected to remain at a stable dose and regimen at least during the main treatment period (Weeks 0-12).
研究组 & 干预措施
Denecimig
Experimental
Denecimig will be administered subcutaneously.
干预措施: Denecimig (Drug)
结局指标
主要结局
Number of treated bleeds
时间窗: From treatment initiation (week 0) until end of main part (week 12)
Measured as count of treated bleeds.
次要结局
- Number of treated bleeds(From initiation of extension part (week 13) up until end of treatment (week 52))
- Number of clinically relevant new bleeds(From treatment initiation (week 0) up until end of treatment (week 52))
- Days of treatment with bypassing agent (BPAs) or coagulation factor VIII (FVIII) products for management of bleeding episodes(From treatment initiation (week 0) up until end of treatment (week 52))
- Occurrence of infections(From treatment initiation (week 0) up until end of study (week 73))
- Occurrence of antidrug antibodies(From treatment initiation (week 0) up until end of study (week 73))
- Denecimig plasma concentration(From treatment initiation (week 0) up until end of treatment (week 52))
研究者
研究点 (83)
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