JPRN-jRCT2080223105未知1 期
Phase I/II Multicenter, Open-label Trial to Evaluate the Safety and Pharmacokinetics of Alpha-1 MP in Patients with Alpha1-Antitrypsin Deficiency
Grifols Japan K.K.0 个研究点目标入组 3 人开始时间: 2016年2月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 3
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Main inclusion criteria:
- •- Subjects with clinically apparent pulmonary emphysema diagnosed by CT scan
- •- Subjects with serum alpha1-PI levels of <50 mg/dL
- •- Subjects whose percentage of force expired volume in 1 second/Forced vital capacity (FEV1/FVC) after inhalation of a bronchodilator is <70 %
排除标准
- •Main exclusion criteria:
- •- Subjects with moderately or severely deteriorated lung function within 4 weeks
- •- Subjects whose percentage of forced expired volume in 1 second (%FEV1) after inhalation of a bronchodilator is <30%
- •- Subjects who have undergone lung transplantation or liver transplantation
研究者
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