Coversin in paroxysmal nocturnal haemoglobinuria (PNH) in patients with resistance to eculizumab due to complement C5 polymorphisms (VIP study 578) - Coversin in PNH patients with resistance to eculizumab

Akari Therapeutics Plc0 个研究点目标入组 1 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Patients with known paroxysmal nocturnal haemoglobinuria (PNH);LDH *1.5 ULN;Resistance to eculizumab proven by both a recognised C5 polymorphism on genetic screening and complement inhibition on CH50 ELISA of <100% at concentrations of eculizumab in excess of 50µg/mL;Willing to self-inject Coversin daily or to receive daily subcutaneous injections by a home nurse or in a doctor*s office or hospital clinic;Willing to receive appropriate prophylaxis against Neisseria infection by either or both immunisation or continuous or intermittent antibiotics;Males or females taking adequate contraceptive precautions if of childbearing potential, 18 * 80 years of age;Body weight * 50kg and * 100kg ;The patient has provided written informed consent.;Willing to avoid prohibited medications for duration of study (see Exclusion Criteria);Must be counselled regarding the possible reproductive risks of using Coversin and be advised to use an adequate method of contraception pending further data on reproductive toxicology.

•Body weight <50kg or > 100kg ;Pregnancy (females);Use of tizanidine (if on ciprofloxacin);Use of eculizumab (Soliris®) should be discontinued before coversin therapy is commenced. Ideally this should be 2 or more weeks before. ;Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom);Failure to satisfy the PI off fitness to participate for any other reason

发起方