EUCTR2019-004430-42-DE进行中（未招募）1 期
Emicizumab in Patients with Acquired Hemophilia A: Multicenter, Single-Arm, Open-Label Clinical Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GWT-TUD GmbH
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Patients diagnosed with AHA based on a reduced FVIII activity (<50 %) and positive FVIII inhibitor (>0.6 BU/ml) at the time of diagnosis (local laboratory)
- •2)Signed informed consent form by the participant or a person who is legally authorized to sign on behalf of the participant before any study specific tests or procedures
- •3)Male or female patients aged 18 years or older at the time of informed consent
- •4)Ability to understand and follow study-related instructions
- •5)Current bleeds due to AHA at the time of screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1)Congenital hemophilia A
- •2) Partial or complete remission of AHA (defined as FVIII:C =50% and no bleeding and no hemostatic therapy) at the time of screening
- •3)Treatment with aPCC within the last 48 h before first study treatment or planned treatment with aPCC during the course of the study
- •4)Treatment of AHA within the days before study enrollment with more than 100 mg prednisolone (or equivalent) per day or prednisolone for more than 2 days or with other immunosuppressive drugs (e.g. rituximab, cyclophosphamide). IST for other concomitant disorders (e.g. autoimmune disorders) is not an exclusion criterion and can be continued at the investigator’s discretion.
- •5)Therapy (current or planned during the emicizumab treatment period) with immunosuppressive or immune modulating drugs that were not already given on a regular basis before first diagnosis of AHA
- •6)Positive lupus anticoagulant at the time of screening
- •7)Severe uncontrolled infection at the time of screening
- •8)Signs of active disseminated intravascular coagulation at the time of screening
- •9)Current treatment for thromboembolic disease or signs of current thromboembolic disease at time of screening
- •10)Patients who are at high risk for TMA (e.g., have a previous medical or family history of TMA), in the investigator’s judgment
- •11)Known severe congenital or acquired thrombophilia
- •12)Life expectancy <3 months at the time of screening
- •13)Other conditions that substantially increase risk of bleeding or thrombosis by the discretion of the investigator
- •14)Contraindications according to the Investigator’s Brochure of emicizumab
- •15)Current treatment with emicizumab at time of screening
- •16)History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection by the discretion of the investigator
- •17)Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose additional risk, or would, in the opinion of the local investigator, preclude the
- •patient’s safe participation in and completion of the study
- •18)Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study by the discretion of the investigator
- •19)Pregnant or breast-feeding women
- •20)Women of childbearing potential unless women who meet the following criteria:
- •a.Post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH > 40 U/mL)
- •b.Postoperatively (six weeks after bilateral ovariectomy with or without hysterectomy)
- •c.Regular and correct use of a contraceptive method with error rate <1% per year such as implants, depot injections, oral contraceptives or intrauterine devices
- •d.Sexual abstinence
- •e.Vasectomy of the partner
- •21)Subject is in custody by order of an authority or a court of law
- •22)Receipt of an investigational drug concurrently or within 5 half-lives before administration of the study drug
研究者
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