EUCTR2019-003957-27-PL进行中（未招募）1 期
A randomized, double-blind, parallel group, placebo-controlled, multi-center study to assess the safety and tolerability of monthly subcutaneous administrations of a low and high dose cohort of osocimab to ESRD patients on regular hemodialysis - CONVERT
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
- 750
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
- •Participants must be at least 18 years of age
- •Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for =3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
- •Body weight of at least 50 kg
- •Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •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 435
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 315
排除标准
- •Recent (<6 months before screening) clinically significant bleeding
- •Hemoglobin (Hb) < 9.0 g/dL at screening
- •Platelet count < 100 x 109/L
- •aPTT or PT > ULN (upper limit of normal)
- •Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total
- •Sustained uncontrolled hypertension (diastolic blood pressure =100 mmHg and/or systolic blood pressure = 180 mmHg)
- •Known intracranial neoplasm, arteriovenous malformation or aneurysm
- •Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
- •Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)
- •Recent (<3 months before screening) major surgery or scheduled major surgery during study participation
- •Scheduled living donor renal transplant during study participation
- •Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
- •Receiving antiplatelet therapy except daily ASA = 150 mg/day
- •Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure
研究者
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