Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

Not Applicable

Active, not recruiting

• Conditions: Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism

• Registration Number: KCT0004556
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

1. 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.
2. Male aged =12 years at the time of signing informed consent.
3. Body weight >25 kg at screening.
4. Congenital severe haemophilia A (FVIII < 1%) or moderate/severe B (FIX = 2%).
5. Documented treatment with coagulation factor containing product in the last 24 weeks (not applicable for patients previously enrolled in NN7415-4255).

Exclusion Criteria

1. Known or suspected hypersensitivity to monoclonal antibodies.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 5 half-lives or 30 days from screening, whichever is longer (not applicable for patients from NN7415-4255).
4. Platelets =100x109/L at screening.
5. Fibrinogen below laboratory lower normal limit at screening.
6. Hepatic dysfunction defined as AST and/or ALT >3 times the upper limit combined with total bilirubin > 1,5 times the upper limit at screening.
7. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) =30 ml/min/1.73 m2 for serum creatinine measured at screening.
8. Known inherited or acquired coagulation disorder other than congenital haemophilia.
9. History of thromboembolic disease*. 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.
10. A known systemic inflammatory condition requiring systemic treatment at screening.
11. Treatment with emicizumab within 180 days before screening.
12. Presence of confirmed inhibitor =0.6 BU at screening.
13. Known history of inhibitors =0.6 BU in the last 5 years according to the medical records.
14. Any disorder, except for conditions associated with haemophilia, which in the investigator’s opinion might jeopardise patient’s safety or compliance with the protocol.
* 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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For haemophilia A patients without inhibitors: The number of treated bleeding episodes (spontaneous and traumatic), For haemophilia B patients without inhibitors: The number of treated bleeding episodes (spontaneous and traumatic)