A prospective controlled study on the effect on bleeding events and joint function in young adults with severe hemophilia A after a 6 month prophylaxis treatment compared to on demand treatment

Bayer HealthCare LLC/Biological Products0 个研究点目标入组 0 人开始时间: 2005年9月12日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Severe hemophilia A (< 1% FVIII) and severe clinical behavior with an average of 2 relevant bleeds per month, no additional bleeding disorder
•30-45 years of age
•Previously treated subject (>100 Exposure days to any FVIII)
•On on-demand therapy with any FVIII
•No history of inhibitor (screening must include a negative inhibitor assay)
•Informed consent signed
•Available results for HIV, HAV, HBV, HCV (can be tested at screening if not available)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Current or prior inhibitor (inhibitor titer of = 0.6 Bethesda units (BU))
•Planned elective orthopedic surgery during the study duration (13 months)
•Presence of an additional bleeding disorder or other medical or psychological condition which could affect treatment efficacy and QoL outcome (e.g. severe symptomatic HIV infection, advanced liver disease, renal failure).
•History of anaphylactic or other severe reaction to previous AHF treatment
•Known hypersensitivity to the active substance, to mouse or hamster protein or to any of the excipients

发起方

Bayer HealthCare LLC/Biological Products