An update on STOPECU ( NCT02574403) -the French Study of the withdrawal from eculizumab treatment which began in late 2015. ( click here for trial details ) and has planned to recruit 60 participants.
The trial has now stopped recruiting more patients and those aHUS patients who have been selected from most if not all of the hospitals listed below will now be observed and data collected about them and their experience following withdrawal of the drug for another year or more until the trial comes to a conclusion in late 2019.
The study has involved the patient visits (physical examination; blood pressure measurement) will be performed every month for 3 months, and every 3 months for 21 months.
Blood (serum creatinine, platelet count, hemoglobin, LDH, haptoglobin) and urine (proteinuria/creatininuria ratio and microscopic hematuria) tests will be performed every 2 weeks from inclusion to M6 and subsequently every month starting M7 Urine dipstick (for albuminuria and microscopic hematuria) will be performed by the patients at home at least twice a week.
Markers of complement activation and bio-markers of endothelial cells activation and immune cells activation will be assessed at baseline, M1, M3, M6, M9, M12, M18 and M24.
The French patients outcomes and information about their aHUS characteristics will be turned into a decision chart ( algorithm) which will help guide decisions about other aHUS patients around the world. It will provide a risk assessment which will support decisions about if and when it is safe to withdraw from eculizumab treatment.
The aHUS patient community around the world should recognise , and reap the benefits of , what the patients in this study are doing.
The lead investigator for this trial is Prof. Fadi Fakhouri of Nantes University Hospital .
Patients at the following hospitals have had the opportunity to participate in the study:
|CH métropole Savoie
|Ch Le Mans
|Le Mans, France
|CH Metz Thionville
|Hôpital Européen Georges Pompidou
|CH Alpes Léman