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ACTIVE NOT RECRUITING
NCT04472169

UPLC-MS/MS Monitoring of Emicizumab Therapy

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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