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)

ovartis Pharma K.K.0 个研究点目标入组 10 人开始时间: 2015年12月11日最近更新: 2023年10月17日

研究概览

暂无简介。

•Inclusion criteria
•- Male and female patients between the age of 18-75 (inclusive), or 18-65 (applicable in Czech Republic) with a diagnosis of PNH prior to screening
•- A documented PNH clone size of 10% or more by RBCs and/or granulocytes
•- 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 is required at least 2 weeks prior to first dosing.
•Other protocol-defined inclusion criteria may apply

•Exclusion criteria
•- 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 active bacterial infection within 2 weeks prior to first dose of LFG316, or recurrent bacterial infections
•- Under active therapy with other agents interfering with the complement system
•- Severe concurrent co-morbidities that are a likely caused by underlying autoimmune diseases other than PNH
•- Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 50 days after the last dose of LFG316.
•Other protocol-defined exclusion criteria may apply

发起方

ovartis Pharma K.K.