EUCTR2019-004431-23-GB进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER, ROLLOVERSTUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF LONG-TERM ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH ALZHEIMER’S DISEASE - WN41874 - Gantenerumab Open Label Extension Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
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
- •All participants who completed the OLEs of Studies WN25203 or WN28745 (i.e., latest version of protocol in their countries, and did not discontinue study drug early) are eligible to participate in this study.
- •Eligible participants must provide written consent signed by them or by the participant’s legally authorized representative before his or her participation in the study
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of ?1% per year during the treatment period and for at least 16 weeks after the last dose of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Participants who meet any of the following criteria will not be eligible for this study:
- •- Prematurely discontinued from the OLEs of Studies WN25203 or WN28745 or from study
- •drug for any reason
- •- Any medical condition that the investigator or Sponsor determines may jeopardize
- •the participant’s safety if he or she continues to receive study treatment
- •- If the participant is unlikely to benefit from gantenerumab therapy, based on
- •disease progression or other factors, or if study participation is otherwise not
- •in the participant’s best interest, by determination of the investigator or Sponsor
- •- Any investigational treatment other than gantenerumab during or since completion
- •of the OLEs of Studies WN25203 or WN28745
- •- Pregnancy
- •- Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal
- •leptomeningeal hemosiderosis)
- •- Evidence of intracerebral macrohemorrhage
研究者
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