NL-OMON56390尚未招募3 期
An open-label, non-randomized extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan (LNP023) in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis - CLNP023B12001B
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 5
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
- 年龄范围
- 12 至 99（—）
入选标准
- •Participants must have completed the treatment period of the CLNP023X2202, or
- •CLNP023B12301 or CLNP023B12302 trial study on study drug.
排除标准
- •Severe concurrent co-morbidities, e.g., advanced cardiac disease (New York
- •Heart Association (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 iptacopan or complying with the requirements of the study.
- •Participants with an active systemic bacterial, viral or fungal infection
- •within 14 days prior to screening,
- •The presence of fever >= 38C (100.4F) within 7 days prior to screening.
- •History of human immunodeficiency virus (HIV) or any other immunodeficiency
- •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
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-NLPharming Technologies B.V.42