Health Condition 1: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study. 2. Male, age â�¥ 12 years at the time of signing informed consent. 3. Severe (FVIII activity haemophilia B or congenital haemophilia A or B with inhibitors, based on medical records at the full discretion of the treating physician. 4. Patients with CHwI treated on-demand: â�¥ 6 treated (with bypassing agent) bleeding episodes within 24 weeks before screening (visit 1) and patients with severe congenital HA/HB treated on-demand: â�¥ 5 treated (with factor product) bleeding episodes within 24 weeks before screening (visit 1). 5. Patients with congenital haemophilia with inhibitors treated with FEIBA�® prophylaxis: â�¥ 2 treated bleeding episodes within 24 weeks before screening (visit 1).
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to monoclonal antibodies. 2. Previous participation in this study. Participation is defined as signed informed consent. 3. Any disorder, except for conditions associated with congenital haemophilia, which in the physicianââ?¬•s opinion might jeopardise patientââ?¬•s safety or compliance with the protocol. 4. Previous treatment with concizumab. Previous treatment is defined as two or more doses administered. 5. Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study. 6. Current or planned treatment with emicizumab. 7. Any known congenital or acquired coagulation disorder other than congenital haemophilia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of treated bleeding episodes from enrolment and up to a maximum of 89 weeksTimepoint: 89 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of all bleeding episodes from enrolment and up to a maximum of 89 weeksTimepoint: 89 weeks | — |
Countries
Algeria, Australia, Bulgaria, Canada, Croatia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Republic of Korea, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd
Outcome results
None listed