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临床试验/EUCTR2020-001762-11-GB
EUCTR2020-001762-11-GB进行中(未招募)1 期

An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials

Corbus Pharmaceuticals, Inc.0 个研究点目标入组 100 人开始时间: 2020年7月23日最近更新:

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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