Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A - alleviate 1

ovo Nordisk A/S0 个研究点目标入组 48 人开始时间: 2016年9月9日最近更新: 2018年11月6日

适应症

试验速览

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•1. Male, age above or equal to 18 years at the time of signing informed consent,(part A).
•2. Male, age above or equal to 12 years at the time of signing informed consent,(part B).
•3. Diagnosis of congenital haemophilia A based on medical records (FVIII activity <1%).
•4. History of more than 150 exposure days to any FVIII containing products.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Previous participation in this trial. Participation is defined as signed informed consent. (Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)
•2. Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load =400.000 copies/mL and/or cluster of differentiation 4+ (CD4+) lymphocyte count =200/µL performed at screening or defined by medical records no older than 6 months)
•3. Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
•4. Inhibitors to FVIII (= 0.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.

发起方