Novo Nordisk A/S
This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.
Haemophilia A and B With and Without Inhibitors
Concizumab
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 90 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label Study Investigating Efficacy, Safety and Pharmacokinetics of Concizumab Prophylaxis in Children Below 12 Years With Haemophilia A or B With or Without Inhibitors |
Actual Study Start Date : | March 24, 2022 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | November 2, 2029 |
Arm | Intervention/treatment |
---|---|
Experimental: Concizumab-naïve patients Concizumab-naïve participants below 12 years of age at the time of consent/assent |
Drug: Concizumab |
Experimental: Patients coming from compassionate use Patients previously treated with concizumab via compassionate use, either on an individual patient basis or through the concizumab compassionate use programme NN7415-4807 |
Drug: Concizumab |
Ages Eligible for Study: | |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Rady Childrens Hosp San Diego
San Diego, California, United States, 92123
Recruiting
Arnold Palmer Children's Hospital
Orlando, Florida, United States, 32806
Not yet recruiting
Nemours Child Orlando Hem/Onc.
Orlando, Florida, United States, 32827
Not yet recruiting
Augusta Univ/Childrens Hosp-GA
Augusta, Georgia, United States, 30912
Recruiting
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Recruiting
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, United States, 46260
Recruiting
Children's Hosp-New Orleans
New Orleans, Louisiana, United States, 70118
Not yet recruiting
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Recruiting
ECU Sickle Cell Comp Clinic
Greenville, North Carolina, United States, 27834
Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Recruiting
St Christopher Hosp for Child
Philadelphia, Pennsylvania, United States, 19134
Recruiting
Vanderbilt Hemostasis Treatment Clinic
Nashville, Tennessee, United States, 37212
Not yet recruiting
Cook Children's Hospital-Hematology-Oncology
Fort Worth, Texas, United States, 76104
Recruiting
Pediatrics Hematology/Oncology Clinic Battle Building
Charlottesville, Virginia, United States, 22908
Not yet recruiting
Haematology and Blood Bank Department
Algiers, British Columbia, Algeria, 16000
Not yet recruiting
CHU Constantine IBN BADIS/ Hematology department
Constantine, Ontario, Algeria, 25000
Not yet recruiting
University Clinical Center of Republic Srpska (545)
Banja Luka, Gujarat, Bosnia and Herzegovina, 78000
Recruiting
UMHAT "Sveti Georgi" Clinica of Pediatric
Plovdiv, Maharashtra, Bulgaria, 4002
Not yet recruiting
BC Children's Hospital
Vancouver, Rajasthan, Canada, V6H 3V4
Recruiting
McMaster Children's Hospital
Hamilton, Uttar Pradesh, Canada, L8N 3Z5
Not yet recruiting
Tallinn Children's Hospital
Tallinn, Kuala Lumpur, Estonia, 13419
Recruiting
Centre Hospitalier Metropole Savoie
Chambery, Penang, France, 73000
Not yet recruiting
Ap-Hp-Hopital de Bicetre-1
Le Kremlin Bicetre Cedex, Terengganu, France, 94275
Recruiting
Ap-Hp-Hopital Necker-1
Paris, Dolnoslaskie, France, 75015
Recruiting
Aghia Sophia Childrens' Hospital
Athens, Dolnoslaskie, Greece, GR-11527
Not yet recruiting
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, Gauteng, Greece, GR 54642
Recruiting
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, Beşevler/Ankara, Greece, GR-54642
Recruiting
Nirmal Hospital Pvt. Ltd.
Surat, India, 395002
Recruiting
Sahyadri Super Speciality Hospital
Pune, India, 411004
Recruiting
J K Lon Hospital
Jaipur, India, 302004
Recruiting
Post Graduate Institute of Child Health
Noida, India, 201303
Not yet recruiting
A.O.U policlinico "G. Rodolico-San Marco"
Catania, Italy, 95123
Recruiting
Dipartimento di Ematologia Univ. Firenze
Firenze, Italy, 50134
Recruiting
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Recruiting
Azienda Ospedaliera-Universitaria Parma
Parma, Italy, 43126
Recruiting
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, Japan, 216-8511
Recruiting
Saitama Children's Med Centre_Hematology-Oncology
Saitama, Japan, 330-8777
Not yet recruiting
Saint George Hospital University Medical Center
Beirut, Lebanon, 961
Not yet recruiting
Hospital Nini
Tripoli, Lebanon, 1434
Recruiting
Centre of Oncology and Hematology, Vilnius University
Vilnius, Lithuania, LT-08406
Not yet recruiting
Hospital Tunku Azizah
Kampung Baru, Malaysia, 50300
Not yet recruiting
Hospital Pulau Pinang
George Town, Malaysia, 10450
Not yet recruiting
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Malaysia, 20400
Not yet recruiting
Sarawak General Hospital
Kuching, Malaysia, 93586
Recruiting
PHI University Clinic for Children's Diseases Skopje
Skopje, North Macedonia, 1000
Recruiting
Klinisk forskningspost
Oslo, Norway, 0372
Recruiting
Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego
Wroclaw, Poland, 50-556
Not yet recruiting
Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego
Wroclaw, Poland, 50-556
Not yet recruiting
Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa
Lublin, Poland, 20-093
Not yet recruiting
Uniwersyteckie Centrum Kliniczne WUM
Warszawa, Poland, 02-091
Not yet recruiting
Clinic of Haematology, Fundeni Clinical Institute
Bucharest, Romania, 022328
Not yet recruiting
Spitalul Clinic de Urgenta pentru Copii Cluj Napoca
Cluj-Napoca, Romania, 400177
Not yet recruiting
Spitalul Clinic Judetean De Urgenta Bihor
Oradea, Romania, 410469
Withdrawn
Children Regional Clinical Hospital
Krasnodar, Russian Federation, 350007
Withdrawn
Morozovskaya municipal children hospital
Moscow, Russian Federation, 119049
Withdrawn
City out-patient clinic 37, City Hemophilia Centre
Saint-Petersburg, Russian Federation, 191186
Not yet recruiting
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, South Africa, 2193
Recruiting
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Recruiting
Hospital Virgen de la Arrixaca - Hematología
El Palmar, Spain, 30120
Recruiting
Hospital Universitario La Paz
Madrid, Spain, 28046
Recruiting
Hospital Universitario Regional de Málaga
Málaga, Spain, 29009
Recruiting
Koagulationscentrum
Göteborg, Sweden, 413 46
Recruiting
King Chulalongkorn Memorial Hospital_Bangkok_0
Bangkok, Thailand, 10330
Recruiting
Ramathibodi Hospital
Bangkok, Thailand, 10400
Recruiting
Siriraj Hospital - Hematology and Oncology
Bangkok, Thailand, 10700
Recruiting
Sunpasitthiprasong Hospital
Ubon Ratchathani, Thailand, 34000
Recruiting
Gazi University
Ankara, Turkey, 06500
Recruiting
Acibadem Adana Hastanesi
Adana, Turkey, 01130
Recruiting
Ege Universitesi Tip Fakultesi
Izmir, Turkey, 35100
Recruiting
Ondokuz Mayis University Medical Faculty Ped. Haematology
Samsun, Turkey, 55139
Recruiting
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Recruiting
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol, United Kingdom, BS2 8BJ
Recruiting
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N 3HR