A multi-centre, randomised, double-blinded, controlled, dose-escalation trial on safety and efficacy of activated recombinant FVII analogue (NN1731) in the treatment of joint bleeds in congenital haemophilia patients with inhibitors.Trial phase: 2

ovo Nordisk A/S0 个研究点目标入组 0 人开始时间: 2008年3月25日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•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 A or B with a current or historical peak inhibitor of >5 BU to human FVIII or IX and known anti-human FVIII or IX anamnestic response
•3.Male subject, 18 years of age or older (=18 years old in UK)
•4.Minimum of 2 joint bleeds (in 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? no
•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

•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 based on medical records at trial entry (visit 1)*
•5.Any clinical signs or history of thromboembolic events
•6.Advanced atherosclerotic disease
•7.Severe liver disease (ALAT > 2 times 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 trial
•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 impose 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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