Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring (EspacECU)
NCT ID: NCT04859608
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2021-10-20
2023-12-28
Brief Summary
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Detailed Description
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A personalized spacing of eculizumab infusions, based on a therapeutic drug monitoring, is expected to improve the patient's quality of life and lead to substantial savings.
For these reasons, the objective of this study is to explore the efficiency of a personalized spacing of eculizumab infusions compared to the usual administration scheme (without personalization) from the French health Insurance perspective. The efficiency will be assessed by estimating the incremental cost per QALY (Quality-Adjusted Life Year) gained at 18 months (duration of follow-up in the clinical trial) and at 5 years thanks to a Markov model.
The total duration of the study is 24 months (6 months of enrolment and 18 months of follow-up).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Therapeutic drug monitoring
Tailored dosing schedule for eculizumab based on therapeutic drug monitoring
Spacing of Eculizumab infusions
Personalized spacing of eculizumab infusions using a pharmacokinetic population model to estimate eculizumab concentration ( a one-week spacing of eculizumab infusion will be decide if predicted eculizumab concentration in the event of spacing is \> 150 mg/L). Spacing of infusion can be decided every 3 months.
Control
Initial eculizumab schedule is continued (real-life arm). No eculizumab dosages are performed in this arm.
No interventions assigned to this group
Interventions
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Spacing of Eculizumab infusions
Personalized spacing of eculizumab infusions using a pharmacokinetic population model to estimate eculizumab concentration ( a one-week spacing of eculizumab infusion will be decide if predicted eculizumab concentration in the event of spacing is \> 150 mg/L). Spacing of infusion can be decided every 3 months.
Eligibility Criteria
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Inclusion Criteria
* 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
2. 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)
3. Atypical Hemolytic and Uremic Syndrome in remission
4. Patients who give informed consent.
Exclusion Criteria
2. Women treated starting or planning a pregnancy.
3. Patients suffering from a typical or secondary microangiopathic hemolytic anemia (drugs, malignancies, autoimmune disease...)
4. Patients under protection of a judicial authority
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire, Amiens
OTHER
University Hospital, Angers
OTHER_GOV
Centre Hospitalier Universitaire de Besancon
OTHER
University Hospital, Caen
OTHER
Centre Hospitalier of Chartres
OTHER
Nantes University Hospital
OTHER
University of Nancy
OTHER
Poitiers University Hospital
OTHER
Rennes University Hospital
OTHER
University Hospital, Rouen
OTHER
University Hospital, Strasbourg, France
OTHER
Centre Hospitalier Universitaire de Nice
OTHER
Hôpital Necker-Enfants Malades
OTHER
Tenon Hospital, Paris
OTHER
University Hospital, Lille
OTHER
Reims University hospital
OTHER
University Hospital, Clermont-Ferrand
OTHER
Assistance Publique Hopitaux De Marseille
OTHER
Hospices Civils de Lyon
OTHER
University Hospital, Tours
OTHER
Responsible Party
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Locations
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CHU Amiens Picardie
Amiens, , France
CHU d'Angers
Angers, , France
Hôpital Tenon
APHP Tenon, , France
CHU Besançon
Besançon, , France
Hôpital de la Côte de Nacre
Caen, , France
Hôpital Louis Pasteur
Chartres, , France
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Hospices Civils de Lyon
Lyon, , France
Hopital de la conception
Marseille, , France
Hôpitaux de Brabois
Nancy, , France
Hotel Dieu
Nantes, , France
Hopital Necker
Necker, , France
Hopital Pasteur 2
Nice, , France
Hôpital de la Milétrie
Poitiers, , France
Hôpital Maison Blanche
Reims, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital de Bois-Guillaume
Rouen, , France
Nouvel Hôpital Civil
Strasbourg, , France
Countries
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Other Identifiers
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DR200088-EspacECU
Identifier Type: -
Identifier Source: org_study_id
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