2022-502084-38-00招募中3 期
(20321) An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer sponsored studies
Bayer Consumer Care AG, Bayer AG71 个研究点 分布在 14 个国家目标入组 258 人开始时间: 2023年5月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 258
- 试验地点
- 71
- 主要终点
- Incidence of TEAEs (Treatment-emergent adverse events)
研究概览
简要总结
Continuation of darolutamide treatment, Safety of darolutamide
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Overall Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment
- •Participants who have not met any treatment discontinuation criteria outlined in the feeder study protocol
- •Willingness to continue practicing acceptable methods of birth control during the study.
排除标准
- •Participant is unable to comply with the requirements of the study.
- •Negative benefit/ risk ratio as determined by the investigator.
- •Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
结局指标
主要结局
Incidence of TEAEs (Treatment-emergent adverse events)
Incidence of TEAEs (Treatment-emergent adverse events)
Incidence of TESAEs (Treatment-emergent serious adverse events)
Incidence of TESAEs (Treatment-emergent serious adverse events)
Incidence of drug-related TEAEs and TESAEs
Incidence of drug-related TEAEs and TESAEs
次要结局
- Frequency of dose modifications
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (71)
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