EUCTR2018-004253-24-GB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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
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
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
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.
- •Participants with an active systemic bacterial, viral or fungal infection
- •within 14 days prior to screening, or
- •The presence of fever = 38oC (100.4oF) within 7 days prior to screening.
- •History of human immunodeficiency virus (HIV) or any other
- •immunodeficiency disease.
- •History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants.
研究者
相似试验
进行中（未招募）
1 期
Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIEUCTR2016-000468-41-FRovartis Pharma Services AG42
进行中（未招募）
1 期
Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAPDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)MedDRA version: 20.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2016-000468-41-GBovartis Pharma Services AG42
进行中（未招募）
1 期
Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAPDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)MedDRA version: 20.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2016-000468-41-ITOVARTIS PHARMA SERVICES AG42
进行中（未招募）
1 期
ong-term efficacy, safety and tolerability of LNP023 in C3G.C3 GlomerulopathyEUCTR2018-004253-24-ESovartis Farmacéutica, S.A.20
招募中
2 期
An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (activated phosphoinositide 3-kinase delta syndrome/p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)NL-OMON54847Pharming Group5