PER-037-20已完成未知
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)
Apellis Pharmaceuticals Inc.,0 个研究点目标入组 0 人开始时间: 2020年11月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
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.
- •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.
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- •1.Subjects who have withdrawn from an APL-2 clinical study.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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