A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients with Haemophilia A

ovo Nordisk A/S0 个研究点目标入组 60 人开始时间: 2011年2月21日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Male patients with severe (baseline FVIII =1%) haemophilia A
•Age <12 years and weight = 11 kg
•Documented history of a minimum 50 EDs to FVIII products
•(prophylaxis/prevention/surgery/on-demand)
•No factor VIII inhibitors ( =0.6 BU/mL) at screening
•Documented negative FVIII inhibitor test(s) ( < 0.6 BU/mL ) or documented FVIII
•recovery tests (within expected normal ranges) within first 50 EDs
•Immunocompetent, defined as either HIV negative or if HIV positive, CD4 >200
•cells/µL according to medical records
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•Any history of FVIII inhibitors (=0.6 BU/mL)
•Surgery planned to occur during trial participation (exceptions are port placement,
•dental extractions, and minor, uncomplicated emergent procedures)
•Platelet count < 50,000 platelets/µL
•Congenital or acquired coagulation disorders other than haemophilia A
•Ongoing treatment or planned treatment during the trial with chemotherapy,
•immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine
•systemic corticosteroids)
•Any disease or condition which, judged by the Investigator, could imply a potential
•hazard to the patient, interfere with the trial participation or trial outcome

发起方