EUCTR2006-004879-35-ES进行中（未招募）1 期
Ensayo multicéntrico, aleatorizado, doble ciego, controlado, de escalada de dosis sobre la seguridad y eficacia de análogo de FVII recombinante activado (NN1731) en el tratamiento de hemorragias articulares en pacientes con hemofilia congénita con inhibidores
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1.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 subject.)
- •2. Clinical diagnosis of congenital haemophilia with current inhibitor to human FVIII or IX and known anti-human FVIII or IX anamnestic response with peak inhibitor titre >5 BU
- •3. Male subject, 12 years of age or older
- •4. Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 12 months at trial entry
- •5. Subject has adequate venous access at screening visit as judged by the Investigator
- •6. The subject or caregiver is capable of assessing the bleed
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known allergy to rFVIIa, and/or suspected allergy to trial product
- •2.Subject is currently participating in another investigational drug study or has participated in any clinical study involving an investigational drug within 30 days of trial enrolment
- •3.Any known congenital or acquired coagulation disorder other than congenital haemophilia
- •4.Platelet count < 50,000/mm3
- •5.Any clinical signs or history of thromboembolic events
- •6.Advanced atherosclerotic disease
- •7.Severe liver disease (ALAT > than 2 times of the upper limit of normal reference range) based on medical records at trial entry
- •8.Known active pseudo tumours (documented bleeding requiring treatment within the last 3 months)
- •9.Presence of any life- or limb-threatening bleeding episode, as judged by the Investigator
- •10.Planned surgery within 9 months after enrolment in this study
- •11.Subject had any (major) surgical procedure in the 30 days prior to screening into the trial
- •a.Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject
- •12.Any disease or condition which, judged by the Investigator, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
- •13.Previous participation in this trial (screened and randomised to more than five NN1731 dose tier groups)
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