NCT04472169Active, not recruiting
UPLC-MS/MS Monitoring of Emicizumab Therapy
Value of Emicizumab Monitoring With UPLC-MS/MS for Bleeding Risk Prediction in Severe Hemophilia A
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 10 Jul 2020
- Start date
- 13 Apr 2022
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- University Hospital, Lille
- Diseases
- Haemophilia
- NCT number
- NCT04472169
What you commit to
- Study type: Observational
- Planned participants: 100
- From 13 Apr 2022 to the primary completion date, 30 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- other inherited or acquired bleeding disorder
Other
- Refusal to give informed consent
- acquired hemophilia A
- bodyweight \< 10 kgs
Who the study is looking for
- Adult or child with Clinical diagnosis of severe hemophilia A (FVIII activity \< 1%) with or without inhibitor
- Clinical indication to emicizumab therapy
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de CAEN Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Institut Coeur-Poumon, Pôle d'Hématologie-Transfusion, CHU Coordinator of this site? Confirm its status | Lille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.