An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 165
- 试验地点
- 111
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug.
- •Male subject agrees to refrain from sperm donation.
- •Female subjects must not be pregnant or breastfeeding.
排除标准
- 未提供
研究组 & 干预措施
Venetoclax
Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).
An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
次要结局
未报告次要终点
