Trials / Unknown
UnknownNCT04472169
UPLC-MS/MS Monitoring of Emicizumab Therapy
Value of Emicizumab Monitoring With UPLC-MS/MS for Bleeding Risk Prediction in Severe Hemophilia A
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2022-04-13
- Primary completion
- 2024-02-01
- Completion
- 2024-02-01
- First posted
- 2020-07-15
- Last updated
- 2023-02-10
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04472169. Inclusion in this directory is not an endorsement.