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UPLC-MS/MS Monitoring of Emicizumab Therapy
Sponsor: University Hospital, Lille
Summary
Emicizumab is a monoclonal bispecific antibody with a terminal half-life of 28 days which is now licensed in the treatment of severe haemophilia A with or without inhibitors. Some heterogeneity in residual emicizumab concentrations have been reported according to age, body mass index or drug therapeutic regimen. Some cases of neutralizing antidrug antibodies have been also reported. Whether monitoring emicizumab plasma concentration could predict the residual bleeding risk under emicizumab is unknown. As conventional coagulation assays are not adapted for emicizumab monitoring, this study aims to assess the value of monitoring residual emicizumab plasma concentration by UPLC-MS/MS in bleeding risk prediction.
Official title: Value of Emicizumab Monitoring With UPLC-MS/MS for Bleeding Risk Prediction in Severe Hemophilia A
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2022-04-13
Completion Date
2026-11
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Locations (2)
CHU de Caen
Caen, France
Institut Coeur-Poumon, Pôle d'Hématologie-Transfusion, CHU
Lille, France