Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients with Congenital Haemophilia and Inhibitors - adept™2

• Conditions: Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; Congenital Haemophilia and Inhibitors; MedDRA version: 14.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.0Level: PTClassification code 10056494Term: Haemophilia B with anti factor IXSystem Organ Class: 10010331 - Congenital, familial and genetic disorders

• Registration Number: EUCTR2010-023803-92-IT
• Lead Sponsor: OVO NORDISK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-14
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 60

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 patient) 2. Male patient with clinical diagnosis of congenital haemophilia A or B and positive inhibitors to coagulation factors VIII or IX (to be confirmed at the Screening Visit -Visit 1) 3. Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry 4. 12 years of age or older 5. For patients when treated at home: The patient or the patients’ caregiver is able (or able to be trained) to reconstitute and administer intravenous trial product, capable of assessing a bleed, efficacy and potential adverse events related to their treatment, and capable of following the trial protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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 or suspected hypersensitivity to trial products or related products 2. Previous participation in this trial defined as withdrawal after administration of trial product 3. Patient has received an investigational medicinal product within 30 days prior to this trial For Brazil, only: The receipt of any investigational drug within one year prior to screening for this trial (Visit 1), unless there, at the investigator discretion, is a direct benefit to the research subject. 4. Congenital or acquired coagulation disorders other than congenital haemophilia A and B 5. Any clinical signs or known history of arterial thrombotic events or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records) 6. Use of any anticoagulant within one week prior to randomisation (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)(Use of anticoagulants to lock an implanted Port e.g. Port-A-Cath is allowed ) 7. Platelet count < 50,000 platelets/µl (at the Screening Visit – Visit 1) 8. ALAT > 3 times the normal upper limit (according to laboratory reference ranges) 9. Creatinine level > 1.5 times the normal upper limit (according to laboratory reference ranges) 10. FVIII/IX Immune Tolerance Induction regimens planned to occur during the trial 11. Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial 12. HIV positive with current CD4+ count < 200/mL (defined by medical records) 13. Any life-threatening disease or other disease or condition which, according to the Investigator’s judgement, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified