NCT01288391已完成1 期
An Open Non-randomised Dose Escalation Trial Investigating the Safety and Pharmacokinetics of Single Intravenous Administrations of NNC128-0000-2011 in Patients With Haemophilia A or B
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Frequency of Adverse Events (AEs)
研究概览
简要总结
This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with haemophilia A or B (with or without inhibitors and irrespective of severity) based on medical records
- •Japan: A legally acceptable representative (LAR) is required for patients between 18 and 19 years
- •Body weight less than or equal to 100.0 kg
- •Body Mass Index (BMI) less than or equal to 30.0 kg/m^2
排除标准
- •Known or suspected allergy to trial product(s) or related products (including rFVIIa)
- •Previous participation in this trial defined as administration of trial product
- •The receipt of any investigational product within 30 days prior to trial start (screening)
- •Congenital or acquired coagulation disorders other than haemophilia A or B
- •Receipt of Immune Tolerance Induction (ITI) within the last 30 days prior to screening
- •Any surgery within 30 days prior to screening
- •Planned surgery within the trial period
- •Platelet count below 50,000 platelets/mcL (based on medical records within the last 1 month or laboratory results at screening)
- •Prothrombin time (PT) above 4 times Upper limit of normal (ULN) or International normalised ratio (INR) greater than 1.7
- •Hepatic dysfunction or severe hepatic disease as evaluated by the investigator (trial physician)
- •Renal dysfunction (dialysis) and/or creatinine levels more than or equal to 20% above upper normal limit (according to medical records or laboratory results at screening)
- •Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
- •Any disease, condition, or medication which, according to the investigator's (trial physician) judgement, could imply a potential hazard to the patient or interfere with the trial participation or trial outcome
- •Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
研究组 & 干预措施
100 mcg/kg
Experimental
干预措施: NNC 0128-0000-2011 (Drug)
200 mcg/kg
Experimental
干预措施: NNC 0128-0000-2011 (Drug)
结局指标
主要结局
Frequency of Adverse Events (AEs)
时间窗: from first trial product administration until 12 weeks after last trial product administration
Frequency of serious adverse events (SAEs)
时间窗: from first trial product administration until 12 weeks after last trial product administration
Frequency of MESIs (Medical Event of Special Interest)
时间窗: from first trial product administration until 12 weeks after last trial product administration
次要结局
- Neutralising antibodies against FVIIa and/or N7-GP(from first trial product administration until 12 weeks after last trial product administration)
研究者
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