CTRI/2020/07/026641招募中2 期
ATLAS-PEDS: An open-label, multinational study of fitusiran prophylaxis in male pediatric subjects aged 1 to less than 12 years with hemophilia A or B - ATLAS-PEDS
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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
入选标准
- •Participant must be 1 to less than 12 years of age at the time of enrollment
- •- Severe hemophilia A or B (FVIII <1% or FIX <=2%)
- •- Participants must have inhibitory antibodies to FVIII or FIX and must meet one of the following Nijmegen-modified Bethesda assay results criteria.
- •1. ÂInhibitor titer of >=0.6 BU/mL at screening
- •2. ÂInhibitor titer of <0.6 BU/mL at screening with medical record evidence of 2 consecutive titers >=0.6 BU/mL
- •3. ÂInhibitor titer of <0.6 BU/mL at screening with medical record evidence of anamnestic response
排除标准
- •- Known co-existing bleeding disorders other than hemophilia A or B, ie, von Willebrand disease, additional factor deficiencies, or platelet disorders
- •- AT activity <60% at screening, as determined by central laboratory analysis.
- •- Presence of clinically significant liver disease, or as indicated by any of the conditions below
- •1. International normalized ratio (INR) >1.2
- •2. ALT and/or AST >2 Ã? ULN reference range
- •3. Total bilirubin >ULN ( >2 Ã? ULN in participants with Gilbertâ??s syndrome
- •4. History of portal hypertension, esophageal varices, or hepatic encephalopathy
- •5. Presence of ascites by physical examination
研究者
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