EUCTR2019-000750-63-NL进行中(未招募)1 期
A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation
AbbVie Deutschland0 个研究点目标入组 189 人开始时间: 2019年8月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 189
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
- •*Adults 18 years or older
- •*Confirmed diagnosis of CF and homozygous for F508del CFTR mutation
- •*Lung function = 40% and = 90% of predicted normal for age, gender, and height
- •*Stable pulmonary status
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 189
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •*Cirrhosis with portal hypertension
- •*History of solid organ or hematopoietic transplantation
研究者
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