drugset / Trial / NCT04859608
Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring (EspacECU)
Phase 3
Completed
40 enrolled
University Hospital, Tours
Assistance Publique Hopitaux De Marseille · collabCentre Hospitalier Universitaire de Besancon · collabCentre Hospitalier Universitaire de Nice · collabCentre Hospitalier Universitaire, Amiens · collabCentre Hospitalier of Chartres · collabHospices Civils de Lyon · collabHôpital Necker-Enfants Malades · collabNantes University Hospital · collabPoitiers University Hospital · collabReims University hospital · collabRennes University Hospital · collabTenon Hospital, Paris · collabUniversity Hospital, Angers · collabUniversity Hospital, Caen · collabUniversity Hospital, Clermont-Ferrand · collabUniversity Hospital, Lille · collabUniversity Hospital, Rouen · collabUniversity Hospital, Strasbourg, France · collabUniversity of Nancy · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Eculizumab is an anti-C5 monoclonal antibody approved for rare diseases including atypical haemolytic-uraemic syndrome. The maintenance phase dosing regimen is identical for all adult patients but several studies have shown a high interindividual kinetics variability. A tailored administration of eculizumab based on therapeutic drug monitoring will be compared with real-life administration in adults suffering from an atypical haemolytic uraemic syndrome. The objective is to improve efficiency of eculizumab administration.
Timeline
- Start
- 2021-10-20
- Primary completion
- 2022-06-16
- Completion
- 2023-12-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eculizumab | Monoclonal antibody | — | Intravenous |