A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors
Condition(s) studied
Investigational drug(s) / intervention(s)
Concizumab: Participants in Arm 1 will be assigned to concizumab prophylaxis starting with a loading dose on treatment day 0 followed by daily injections of an individual maintenance dose. Participants in Arm 2 will be assigned to concizumab prophylaxis with daily injections of an individual maintenance dose.
Study summary
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.
Eligibility
Primary outcome measure(s)
- For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes — From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Count of episode(s) - For non-inhibitor patients treated on demand during at least the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes — From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Count of episode(s)
Trial sites (91)
| Facility | City | Region | Status |
|---|---|---|---|
| Rady Childrens Hosp San Diego | San Diego | California | |
| University of Colorado Hospital | Aurora | Colorado | |
| Arnold Palmer Children's Hospital | Orlando | Florida | |
| Nemours Child Orlando Hem/Onc. | Orlando | Florida | |
| Augusta Univ/Childrens Hosp-GA | Augusta | Georgia | |
| Memorial Health University Medical Center | Savannah | Georgia | |
| Childrens Hospital of Chicago | Chicago | Illinois | |
| Indiana Hemophilia-Thromb Ctr | Indianapolis | Indiana | |
| Children's Hosp-New Orleans | New Orleans | Louisiana | |
| Ochsner Clinic Foundation | New Orleans | Louisiana | |
| The Children's Mercy Hospital | Kansas City | Missouri | |
| Children's Nebraska | Omaha | Nebraska | |
| ECU Sickle Cell Comp Clinic | Greenville | North Carolina | |
| Nationwide Children's Hospital | Columbus | Ohio | |
| St Christopher Hosp for Child | Philadelphia | Pennsylvania | |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | |
| Cook Children's Hospital-Hematology-Oncology | Fort Worth | Texas | |
| Texas Children's Hospital_Houston | Houston | Texas | |
| Pediatrics Hematology/Oncology Clinic Battle Building | Charlottesville | Virginia | |
| Haematology and Blood Bank Department | Algiers | Algeria | |
| CHU Constantine BEN BADIS/ Hematology department | Constantine | Algeria | |
| University Clinical Center of Republic Srpska (545) | Banja Luka | Bosnia and Herzegovina | |
| University Clinical Centre Tuzla | Tuzla | Bosnia and Herzegovina | |
| UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics | Plovdiv | Bulgaria | |
| UMHAT Tsaritsa Yoanna - ISUL EAD, Pediatric clinical hematology and oncology | Sofia | Bulgaria | |
| UMHAT Sveta Marina EAD, Clinic of Pediatric Clinical Hematology and Oncology | Varna | Bulgaria | |
| BC Children's Hospital | Vancouver | British Columbia | |
| McMaster Children's Hospital | Hamilton | Ontario | |
| Tallinn Children's Hospital | Tallinn | Estonia | |
| Centre Hospitalier Metropole Savoie | Chambéry | France | |
| Ap-Hp-Hopital de Bicetre-1 | Le Kremlin-Bicêtre | France | |
| AP-HP-HOPITAL NECKER_Service d'hématologie | Paris | France | |
| Aghia Sophia Childrens' Hospital | Athens | Greece | |
| 'Ippokrateio' General Hospital of Thessaloniki | Thessaloniki | Greece | |
| 'Ippokrateio' General Hospital of Thessaloniki | Thessaloniki | Greece | |
| Guwahati Medical College | Guwahati | Assam | |
| Nirmal Hospital Pvt. Ltd. | Surat | Gujarat | |
| SSSH_Dept. of Clinical Haematology & Haemato Oncology | Kolhāpur | Maharashtra | |
| Seth GS Medical College & KEM Hospital | Mumbai | Maharashtra | |
| K.J Somaiya Hospital and Research Centre | Mumbai | Maharashtra |
+ 51 more sites — see the full list on the official registry below.
More Novo Nordisk A/S trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05135559 on ClinicalTrials.gov ↗ ← All trials in France