JPRN-jRCT2031200303已完成2 期
Factor XI LICA to Reduce Thrombotic Events in End-Stage Renal Disease Patients on Hemodialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of BAY 2976217 - RE-THINc ESRD
Myoishi Masashi0 个研究点目标入组 288 人开始时间: 2021年1月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 288
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Participant must be at least 18 years of age at the time of signing the informed consent form (ICF)
- •- Participants with ESRD on hemodialysis (HD) for >=3 months at the time of signing of the ICF, receiving dialysis at least 9 hours a week and stable in the view of the investigator
- •- Male 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)
- •- Capable of giving signed ICF as described in the Protocol, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
排除标准
- •- Participant must be at least 18 years of age at the time of signing the informed consent form (ICF)
- •- Participants with ESRD on hemodialysis (HD) for >=3 months at the time of signing of the ICF, receiving dialysis at least 9 hours a week and stable in the view of the investigator
- •- Male 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)
- •- Capable of giving signed ICF as described in the Protocol, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
研究者
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