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Active (not recruiting) Phase 3 NCT04083781

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

Phase 3 – large-scale trial before approval
Conditions: Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
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 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. Which treatment the participant gets is 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 get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and 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 seven years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (31 December 2026 at the latest). The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.
Who can participate
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 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 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. * 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.)
Locations 27
Algeria (1)
Haematology and Blood Bank Department
Algiers
Australia (1)
The Alfred
Melbourne , Victoria
Bulgaria (1)
UMHAT Tsaritsa Yoanna - ISUL EAD, Pediatric clinical hematology and oncology
Sofia
Canada (1)
Hamltn Hth Sci/McMstr Child Hosp
Hamilton , Ontario
Croatia (1)
KBC Zagreb, Rebro, Hemofilija centar
Zagreb
Czech Republic (1)
Ustav Hematologie a krevni tranfuze
Prague
Denmark (1)
Skejby Blodsygdomme, blødercentret
Aarhus N
France (1)
Hospices Civils de Lyon- Hopital Louis Pradel
Bron
India (1)
St. John's Medical college and Hospital
Bangalore , Karnataka
Italy (1)
Dipartimento di Ematologia Univ. Firenze
Florence , FI
Japan (1)
Nagoya University Hospital_Blood Transfusion
Aichi
Malaysia (1)
Hospital Pulau Pinang_Georgetown, Penang
George Town , Pulau Pinang
Mexico (1)
Hospital Universitario Dr. José Eleuterio González
Monterrey , Nuevo León
Norway (1)
Rikshospitalet - avdeling for blodsykdommer
Oslo
Poland (1)
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan , Greater Poland Voivodeship
Russia (1)
Children Regional Clinical Hospital
Krasnodar
Serbia (1)
Clinical Centre of Serbia, Institute for Haematology
Belgrade
Slovakia (1)
Nemocnica sv. Cyrila a Metoda, UNB,Klinika hemat. a transfuz
Bratislava
South Africa (1)
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg , Gauteng
South Korea (1)
Daejeon Eulji Medical Center, Eulji University
Daejeon
Spain (1)
Hospital Vall d'Hebron
Barcelona
Sweden (1)
Koagulationsmottagning - SUS
Malmo
Thailand (1)
Sunpasitthiprasong Hospital_Pediatrics Department
Ubon Ratchathani , Mueang Distirct,
Turkey (1)
İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Onkoloji Enstitüsü
Capa-ISTANBUL , Capa-ISTANBUL
Ukraine (1)
National specialized children's hospital 'OHMATDYT' - Haemostasis centre
Kyiv
United Kingdom (1)
Queen Elizabeth Hospital, Birmingham - Haemophilia
Birmingham
United States (1)
Center for Inherited Blood Dis
Orange , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male only
Healthy volunteers
No
Start date
21.10.2019
Completion date
21.02.2027
Registry ID
NCT04083781
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.