Status:
COMPLETED
Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring (EspacECU)
Lead Sponsor:
University Hospital, Tours
Collaborating Sponsors:
Centre Hospitalier Universitaire, Amiens
University Hospital, Angers
Conditions:
Hemolytic-Uremic Syndrome, Atypical
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 sev...
Detailed Description
Eculizumab is a very expensive drug (450 000 euros per year per patient). According to the usual administration scheme, the eculizumab is administrated by intravenous infusion, every 14 or 21 days in ...
Eligibility Criteria
Inclusion
- Adults with an atypical Hemolytic and Uremic Syndrome defined by at least 2 of the following parameters:
- Thrombopenia (platelet count \< 150 G/L)
- Mechanical lytic anemia (Hb \< 10 g/L, Lactate dehydrogenase \> upper limit of normal, undetectable haptoglobin, presence of schistocytes on blood smear)
- Acute renal failure
- Eculizumab treatment
- Without project of withdrawal in the next 18 months
- Started since at least 6 months
- Administrated with an unchanged administration schedule since at least 3 months (initial episode or relapse)
- Atypical Hemolytic and Uremic Syndrome in remission
- Patients who give informed consent.
Exclusion
- Patients on dialysis.
- Women treated starting or planning a pregnancy.
- Patients suffering from a typical or secondary microangiopathic hemolytic anemia (drugs, malignancies, autoimmune disease...)
- Patients under protection of a judicial authority
Key Trial Info
Start Date :
October 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04859608
Start Date
October 20 2021
End Date
December 28 2023
Last Update
March 25 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Amiens Picardie
Amiens, France
2
CHU d'Angers
Angers, France
3
Hôpital Tenon
APHP Tenon, France
4
CHU Besançon
Besançon, France