Status:
ACTIVE_NOT_RECRUITING
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Haemophilia A Without Inhibitors
Haemophilia B Without Inhibitors
Eligibility:
MALE
12+ years
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 without inhibitors. The purpose is to show that concizumab can prevent bleeds in the ...
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 severe haemophilia A (FVIII below 1%) or B (FIX equal to or below 2%).
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.
- Presence of confirmed inhibitors 0.6 BU or greater at screening.
- 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 :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2028
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04082429
Start Date
November 13 2019
End Date
February 21 2028
Last Update
December 5 2025
Active Locations (108)
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1
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States, 90027
2
Center for Inherited Blood Disorders
Orange, California, United States, 92868
3
Center for Blood Disorders Augusta University
Augusta, Georgia, United States, 30912
4
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, United States, 46260