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

  • STATUS
    Recruiting
  • End date
    Dec 19, 2024
  • participants needed
    158
  • sponsor
    Novo Nordisk A/S
Updated on 8 January 2022

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 body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. The group will be decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with study medicine every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about three years. Participants will have to come to the clinic for up to 33 times. The time between visits will be approximately 4 weeks for the first 6 to 12months depending on the group participants are in, and approximately 8 weeks for the rest of the study. At all visits, blood samples will be taken. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

Details
Condition Haemophilia A Without Inhibitors, Haemophilia B Without Inhibitors
Treatment Concizumab
Clinical Study IdentifierNCT04082429
SponsorNovo Nordisk A/S
Last Modified on8 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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.)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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