Status:
ACTIVE_NOT_RECRUITING
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the bod...
Eligibility Criteria
Inclusion
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Male aged 12 years or older at the time of signing informed consent.
- Congenital Haemophilia A or B of any severity with documented history of inhibitor (equal to or above 0.6 Bethesda Units (BU).
- Patient has been prescribed, or in need of, treatment with bypassing agents in the last 24 weeks prior to screening (for patients not previously enrolled in NN7415-4310 (explorer 4)).
Exclusion
- Known or suspected hypersensitivity to any constituent of the trial product or related products.
- Known inherited or acquired coagulation disorder other than congenital haemophilia.
- Ongoing or planned Immune Tolerance Induction treatment.
- History of thromboembolic disease (includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion). Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events (thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events.)
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04083781
Start Date
October 21 2019
End Date
February 21 2027
Last Update
January 6 2026
Active Locations (97)
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1
Center for Inherited Blood Dis
Orange, California, United States, 92868
2
Children's Healthcare Atlanta
Atlanta, Georgia, United States, 30329
3
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, United States, 46260
4
Washington University School of Medicine_St. Louis
St Louis, Missouri, United States, 63110