CTIS2023-503803-27-00招募中1 期
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study - PCI-32765CAN3001
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 208
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants must be currently participating in a ibrutinib clinical study considered completed and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib OR Subjects must have participated in a ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and subjects with less than 6 months will be required to have more frequent initial safety assessments, Agrees to protocol-defined use of effective contraception, Negative blood or urine pregnancy test at screening
排除标准
- •Requires anticoagulation with warfarin or equivalent vitamin K antagonists, Requires treatment with strong cytochrome P450 (CYP)3A4/5inhibitors, unless previously approved by sponsor, Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study
研究者
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