NCT01392547已完成3 期
Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given
研究概览
简要总结
This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.
详细描述
Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
- •Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry
排除标准
- •Previous participation in this trial defined as withdrawal after administration of trial product
- •Patient has received an investigational medicinal product within 30 days prior to this trial
- •Congenital or acquired coagulation disorders other than haemophilia A or B
- •Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
- •Platelet count of less than 50,000 platelets/mcL (at the screening visit)
- •ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
- •Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
- •Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
- •HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)
研究组 & 干预措施
rFVIIa
Experimental
干预措施: eptacog alfa (activated) (Drug)
vatreptocog alfa
Experimental
干预措施: vatreptacog alfa (activated) (Drug)
结局指标
主要结局
Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given
时间窗: Within 12 hours of first trial product administration
次要结局
- Number of Adverse Events(Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.)
- Effective and Sustained Bleeding Control(Up to 48 hours after first trial product administration)
- Number of Doses of Trial Product Given for Each Acute Bleed(Up to 6 hours after first trial product administration)
- Immunogenicity (Inhibitor Development)(Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.)
研究者
研究点 (1)
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