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 - ND

Conditions: Haemophilia A with antifactor VIII and Haemophilia B with antifactor IX
MedDRA version: 9.1Level: LLTClassification code 10056492Term: Haemophilia A with anti factor VIII

Registration Number: EUCTR2006-004879-35-IT

Lead Sponsor: OVO NORDISK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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)