Somaiya Vidyavihar University | K.J Somaiya Hospital and Research Centre
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Volunteers
Inclusion criteria
Informed consent/assent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Diagnosis of congenital severe haemophilia A (FVIII below 1%) or moderate/severe congenital haemophilia B (FIX (coagulation factor IX) below or equal to 2%), or congenital haemophilia with inhibitors.
For arm 1 only: Male aged below 12 years of age at the time of signing informed consent.
For arm 1 only: Patients with inhibitors (haemophilia A with inhibitors or haemophilia B with inhibitors)
For arm 1 only: Patients without inhibitors (haemophilia A or haemophilia B)
For arm 2 only: Male patients (regardless of age) previously treated with concizumab via compassionate use.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
90 participants in 2 patient groups
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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