EUCTR2014-005338-74-CZ进行中（未招募）1 期
An open-label proof of concept study to assess the efficacy, safety and pharmacokinetics of LFG316, an anti-C5 monoclonal antibody in patients with paroxysmal nocturnal hemoglobinuria (PNH) - CLFG316X2201
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
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 patients >= 18 years old with a diagnosis of PNH prior to screening. Based on local requirements (applicable in Czech Republic) only patients between the age of 18-65 (inclusive) with a diagnosis of PNH prior to screening may be eligible for inclusion in this study.
- •A documented PNH clone size of =10% by RBCs and/or granulocytes, measured by GPI-deficiency on flow cytometry.
- •Serum LDH levels at least 1.5-fold above the upper limit of normal (ULN) at screening.
- •Negative pregnancy test for women of child bearing potential at screening.
- •Previous vaccination against Neisseria meningitidis types A, C, Y and W-135 is required at least 2 weeks prior to first dosing. Vaccination against meningitidis type B should be conducted if available and acceptable by local regulations, at least 2 weeks prior to first dosing.
- •Subjects to be included in this study after protocol amendment 6 also have to fulfill criterion: PNH patients that are carriers of the C5 gene minor variants as defined by nucleic acid changes that lead to amino acid exchanges in position p.Arg885.
- •.Additional inclusion criteria for period 4
- •- Patients participating in period 3 of the current study who are willing to join long term extension study with LNP023 (CLNP023C12001B)
- •- Previous vaccination for the prevention of S. pneumoniae and H. influenzae at least 2 weeks prior to first dosing with LNP023 if locally available. If LNP023 treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment must be initiated.
- •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 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Known or suspected hereditary complement deficiency.
- •History of recurrent meningitis, history of meningococcal meningitis despite vaccination
- •Presence or suspicion (based on judgment of the investigator) of severe active bacterial infection within 2 weeks prior to first dose of LFG316, or severe recurrent bacterial infections .
- •Under active therapy with other agents interfering with the complement system
- •Co-morbidities that are a likely caused by underlying autoimmune diseases other than PNH
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 50 days after the last dose of LFG316.
- •Severe concurrent co-morbidites,eg: patients with severe kidney disease (dialysis),advanced cardiac disease (NYHA class IV) severe pulmonary artierial hypertension (WHO classIV) severe or unstable thrombotic event not amenable to active treatment as judged by the investigator.
- •Either on of the following laboratory abnormalities at screening:
- •a. Neutrophils <0.5 x 1000000000/L
- •b.Platelets<30x1000000000/L
- •.Prohibited medication : targeting complement pathway. For period 4 only :co-medications that inhibit multiple disposition mechanisms of LNP023, Strong CYP2C8 inhibitors such as Clopidogrel, Compounds that have a narrow therapeutic index and are substrates for Pglycoproteins
研究者
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