uwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER) - GENA-22

Octapharma AG0 个研究点目标入组 50 人开始时间: 2023年1月31日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Severe haemophilia A (FVIII activity [FVIII:C] <1%) according to medical history., Male patients at least 12 years of age., Previous treatment with any FVIII product(s) for at least 150 exposure days., On regular prophylaxis with emicizumab for at least 3 months prior to a scheduled major elective surgery requiring FVIII treatment., Freely given written informed consent.

•Coagulation disorder other than haemophilia A., Present or past FVIII inhibitor (=0.6 Bethesda units [BU]/mL) according to medical history., Severe liver or kidney disease (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels >5 times the upper limit of normal; or creatinine >120 µmol/L)., Current participation in another interventional clinical trial., Treatment with any investigational product within 30 days prior to screening visit., Known hypersensitivity to Nuwiq’s active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188), Already had surgery in this study

发起方