EUCTR2005-000891-42-DK进行中（未招募）不适用
A randomised, open-label, multi-centre trial investigating the intra-subject variability of ROTEM® and TEG® parameters following two intravenous administrations of the same dose of activated recombinant factor VII (rFVIIa/NovoSeven®) in haemophilia patients in a non-bleeding state
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the patient.)
- •Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C or FIX:C one stage activity, respectively, at less than 5% of normal (based on medical records) +/- inhibitors (a positive inhibitor status defined as >0.6 Bethesda units)
- •Male subjects, 16 years of age or more
- •Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product
- •Are the trial subjects under 18? yes
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known or suspected allergy to trial product or any of its components or to related products
- •Previous participation in this trial defined as randomisation of the patient
- •Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
- •Platelet count < 50,000 platelets/µL
- •Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for rFVIIa
- •Received rFVIIa within the last 48 hours prior to administration of trial product
- •Participation in any other trial involving investigational products within the last 30 days prior to administration of trial product
- •Received immunosuppressive-immunomodulatory drugs within the last 30 days prior to administration of trial product
- •Advanced atherosclerotic disease, incl. any history of thrombotic disorder (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke or peripheral arterial thrombosis)
- •Septicaemia, e.g. febrile illness within 5 days prior to trial product administration
- •Renal insufficiency defined as current dialysis therapy or creatinine levels above normal range (according to local laboratory range)
- •Hepatic disease
- •? Patients with significant hepatic enzyme elevation (ALAT x 2 upper reference limit and/or PT<70%)
- •? Known current hepatic dysfunction or severe hepatic disease during the last 12 months.
- •Any disease or condition which, according to the Investigator´s judgement, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
研究者
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