Clinical Trial: UPLC-MS/MS Monitoring of Emicizumab Therapy

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: OBSERVATIONAL




Official Title: Value of Emicizumab Monitoring With UPLC-MS/MS for Bleeding Risk Prediction in Severe Hemophilia A

Brief 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.