EUCTR2020-003172-41-CZ进行中（未招募）1 期
A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who are naive to complement inhibitor therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •- Male and female participants = 18 years of age with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with RBCs and WBCs clone size = 10%
- •- Mean hemoglobin level <10 g/dL • LDH > 1.5 x Upper Limit of Normal (ULN)
- •- Vaccination against Neisseria meningitidis infection is required, and is
- •recommended at least 2 weeks prior to initiation of iptacopan treatment.However, administration of these vaccines less than 2 weeks prior to start of iptacopan treatment or up to 2 weeks (up to Day 14) after iptacopan initiation, is at the discretion of the investigator. If iptacopan treatment is started less than 2 weeks post-vaccination or before a specific vaccination is given, participant must be given prophylactic antibiotic at the start of iptacopan and for at least 2 weeks after vaccination.
- •-If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae should be given (if available
- •and according to local/national regulations), and are recommended at
- •least 2 weeks prior to initiation of iptacopan treatment. However,
- •administration of these vaccines less than 2 weeks prior to start of
- •iptacopan treatment or up to 2 weeks (up to Day 14) after iptacopan
- •initiation, is at the discretion of the investigator. If iptacopan treatment
- •is started less than 2 weeks post-vaccination or before a specific
- •vaccination is given, participant must be given prophylactic antibiotic at
- •the start of iptacopan and for at least 2 weeks after vaccination.
- •Other protocol defined inclusion/exclusion criteria may apply.
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Prior treatment with a complement inhibitor, including anti-C5 antibody
- •- Known or suspected hereditary complement deficiency
- •- History of hematopoietic stem cell transplantation
- •- Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L; platelets <30x109/L; neutrophils <0.5x109/L).
- •- Active systemic bacterial, viral (incl. COVID-19)or fungal infection within 14 days prior to study drug administration
- •- History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus.
- •- Major concurrent comorbidities including but not limited to severe kidney disease (e.g., dialysis), advanced cardiac disease (e.g., NYHA class IV heart failure), severe pulmonary disease (e.g., severe pulmonary hypertension (WHO class IV)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes participant's participation in the study.
- •Other protocol defined inclusion/exclusion criteria may apply.
研究者
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