EUCTR2016-004129-18-NL进行中（未招募）1 期
CONSERVE: Coversin Long Term Safety and Efficacy Surveillance Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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)Patients 18 years and above successfully treated with Coversin under other Akari clinical trial protocols and wish to remain on Coversin at the conclusion of that trial.
- •2)On a stable dose of Coversin for at least 2 weeks prior to entering the AK581 long term safety and efficacy surveillance study.
- •3)Evidence of sustained total complement inhibition by CH50 assay.
- •4)An appropriately qualified clinician is willing to keep the patient under observation and treatment whilst on Coversin and to be named as an investigator in this trial.
- •5)Willing to give informed consent .
- •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 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1)Patient is unwilling to continue on Coversin.
- •2)Patient is unwilling to complete the Quaity of Life instruments and diary card.
- •3)Evidence of active meningococcal infection(swab testing not required).
- •4)On concurrent treatment with another complement inhibitor.
- •5)Any other reason for which, in the opinion of the investigator, it would not be in the interests of the patient to remain on Coversin
研究者
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