EUCTR2017-003324-67-BG进行中（未招募）1 期
Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors - n.a.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 24
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
- Male
入选标准
- •1. Male severe hemophilic patients with undetectable FVIII activity <1% or FIX activity <2%, with or without inhibitors (any titer) are eligible.
- •Note: Subjects with a past history of inhibitors (any inhibitor titer) are eligible.
- •2. Age =18 years.
- •3. Documentation of =4 bleeding episodes (any type or location of bleeds, treated or not) within the 6 months prior to screening.
- •4. For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.
- •5. For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing ITI.
- •6. Signed informed consent.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. History of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder.
- •2. History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.
- •3. Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes).
- •4. History of cardiac, coronary and/or arterial peripheral atherosclerotic disease, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris or treatment for angina pectoris.
- •5. Platelet count <100,000/µL.
- •6. Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of <200/mm3.
- •7. Any planned major surgical intervention.
- •8. Subjects with known or suspected hypersensitivity to trial product(s) or related products.
- •9. Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
- •10. Subjects with advanced liver disease (Child-Pugh Grade B and C) or with signs of liver function impairment (e.g., alanine aminotransferase [ALT] and aspartate aminotransferase [AST] levels >3 × the upper limit of the normal range and/or total bilirubin >2 × the upper limit of the normal range).
- •11. Subjects with serum creatinine >2.0 times the upper limit of the normal range.
- •12. Treatment with an investigational drug within 3 months prior to screening visit.
- •13. Subjects not willing to stop prophylaxis or ITI.
研究者
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