Health Condition 1: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism Health Condition 2: null- Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
Conditions
Interventions
Intervention1: NNC 0078-0000-0007
: eptacog alfa (activated)
Intervention2: NNC 0078-0000-0007: 1-3 doses per bleeding episode
Control Intervention1: eptacog alfa (activated)
: 1-3 doses per bleedin
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion 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 start
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective bleeding control defined as no additional haemostatic medication (other than trial product) givenTimepoint: within 12 hours of first trial product administration | — |
Secondary
| Measure | Time frame |
|---|---|
| -Effective and sustained bleeding control -Number of doses of trial product given for each acute bleed -Number of adverse events -ImmunogenicityTimepoint: -up to 48 hours after first trial product administration -up to 6 hours after first trial product administration -after approximately 21 months (at end of trial) -after approximately 21 months (at end of trial) | — |
Countries
France, Greece, Hungary, Italy, Japan, Malaysia, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom
Contacts
Public ContactMr Avik Ghosh
Novo Nordisk India Private Ltd.
Outcome results
None listed