Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)