EUCTR2020-001762-11-DE进行中(未招募)1 期
An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 100
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
- •Consented subjects who completed, or discontinued from, a Corbus sponsored pivotal clinical study and do not enter an open-label extension (OLE) phase of a Corbus sponsored pivotal clinical trial study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Subjects who were randomized in a Corbus sponsored pivotal clinical study but did not receive at least one dose of study treatment (lenabasum or placebo).
- •2. Subjects who enroll in an OLE phase of a Corbus sponsored study.
研究者
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