Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children with Haemophilia B - paradigm™5

OVO NORDISK0 个研究点目标入组 24 人开始时间: 2012年10月9日最近更新: 2024年3月12日

适应症

试验速览

暂无简介。

•- Male patients with moderately severe or severe congenital haemophilia B with a FIX activity level =2% according to medical records - Age = 12 years (until patient turns 13 years, at time of inclusion) - Body weight =10 kg - History of at least 50 EDs to other FIX products - The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an eDiary, capable of conducting home treatment and otherwise able to follow trial procedures
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 24
•F.1.2 Adults (18-64 years) no
•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

•- Known history of FIX inhibitors - Current FIX inhibitors =0.6 BU (central laboratory) - Congenital or acquired coagulation disorder other than haemophilia B - Platelet count <50,000/µL at screening - Alanine aminotransferase (ALT) >3 times the upper limit of normal reference ranges at screening - Creatinine level =1.5 times above the upper normal limit of normal reference ranges at screening - Human immunodeficiency virus (HIV) positive, defined by medical records, and with a CD4+ lymphocyte count =200/µL - Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids) - Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)

发起方

OVO NORDISK