Version testing of EnzySystem Version A for Hemophilia A - HEMSTOL77 - EnzySystem

Radboud Universitair Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•Healthy volunteers:
•Age between 20between 20 to 70 years old (equally distributed over the age
•- 7 volunteers 20-40 years old
•- 7 volunteers 40-60 years old
•- 6 volunteers 60+ years old
•Hemophilia A patients:
•Diagnosed with mild (FVIII activity levels 5-40%), moderate (FVIII activity
•levels 1-5%) or severe hemophilia A (FVIII activity levels <1%)
•- On demand treatment
•- Washout of medication of at least 24 hours after treatment with short half
•life (SHL) replacement therapy
•- Washout of medication of at least 72 hours after treatment with extended half
•life (EHL) replacement therapy
•Age 20-70 years old

•A healthy volunteer who meets any of the following criteria will be excluded
•from participation in this study:
•use of anticoagulants or platelet antagonists (aspirin or any TAR);
•known allergy to stainless steel;
•trauma or surgery within the last two weeks;
•- antimicrobial medication;
•- thyroid inhibitors; or SSRI*s.
•A hemophilia A patient who meets any of the following criteria will be excluded
•from participation in this study:
•use of anticoagulants or platelet antagonists (aspirin or any TAR);
•known allergy to stainless steel;
•trauma or surgery within the last two weeks;
•a bleeding episode within the last two weeks;
•clinical indication of liver cirrhosis (echographic indication, enlarged
•spleen, decreased platelet count);
•acquired FVIII inhibitors;
•- antimicrobial medication;
•- thyroid inhibitors or SSRI*s;
•- Emicizumab.

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