CTIS2022-502061-17-00进行中（未招募）1 期
uwiq Dosing and outcomes In the ManagEment of women/girls with haemophilia A Needing FVIII treatment for Surgery – an International, Open-label, Non-controlled study (NuDIMENSION) - GENA-23
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 65+（—）
入选标准
- •Women/girls with haemophilia A (FVIII activity [FVIII:C] =1 - <40%) according to medical history, At least 12 years of age, Scheduled to undergo major elective surgery requiring FVIII treatment, Freely given written informed consent
排除标准
- •Coagulation disorder other than haemophilia A, Present or past FVIII inhibitors (=0.6 Bethesda units [BU]/mL), 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), Pregnancy, Current participation in another interventional clinical trial, Treatment with any investigational medicinal product (IMP) 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
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