EUCTR2019-001106-23-FR进行中（未招募）1 期
An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 119
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
- •1. Subjects with PNH who have participated in an APL-2 clinical trial.
- •Subjects who received treatment with APL-2 must have experienced
- •clinical benefit in the opinion of the Investigator.
- •Note: Subjects with PNH who completed an APL-2 clinical trial without
- •receiving APL-2 (or without receiving APL-2 for long enough to
- •demonstrate clinical benefit) may be enrolled in this study if, in the
- •opinion of the Investigator, the subject is expected to demonstrate
- •clinical benefit upon the initiation or continuation of APL-2 therapy.
- •2. Willing and able to give written informed consent.
- •3. Women of child-bearing potential (WOCBP) must have a negative
- •pregnancy test and must agree to continue to use an approved method
- •of contraception for the duration of the study and 60 days after their last
- •dose of study drug.
- •4. Males must agree to continue to use an approved method of
- •contraception and must agree to refrain from donating sperm for the
- •duration of the study and 60 days after their last dose of study drug.
- •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 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Subjects who have withdrawn from an APL-2 clinical study
- •2. Any condition that could increase the subject’s risk by participating in the study
研究者
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