EUCTR2018-004253-24-ES进行中（未招募）1 期
An open-label, non-randomized extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy.
ovartis Farmacéutica, S.A.0 个研究点目标入组 20 人开始时间: 2019年7月4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
- 20
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
入选标准
- •Patients must have completed the treatment period of the CLNP023X2202 trial on 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 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study.
- •Patients with an active infection requiring medical treatment.
- •Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV) virus.
- •History of HIV or any other immunodeficiency disease.
- •History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects.
研究者
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