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Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU
Sponsor: University Hospital, Toulouse
Summary
The investigators aim to perform the first controlled randomized prospective study using ECZ in pediatric STEC-HUS. This is of great interest as there is still no efficient specific therapy in that potentially devastating disease. Furthermore, published data concerning the use of ECZ in STEC-HUS are controversial, reflecting statistical bias in retrospective or uncontrolled studies, thus emphasizing the need for prospective studies.
Official title: Early Treatment With the Monoclonal C5 Antibody Eculizumab in Pediatric Patients Affected by Shiga-toxin Related Hemolytic and Uremic Syndrome: A Phase III Prospective Randomized Controlled Therapeutic Trial Versus Placebo
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2015-06
Completion Date
2018-06
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
Eculizumab
According to the patient body weight, there will be 3 to 5 injections at D0, D7, D14, D21 and D28. According to the length of initial hospital stay, patients may have the remaining injections in the day ward of the recruiting center. Dosage of ECZ will be based on previous trials using ECZ in pediatric aHUS patients. ECZ or placebo will be administrated intravenously as a 30-minute injection
Placebo
According to the patient body weight, there will be 3 to 5 injections at D0, D7, D14, D21 and D28. ECZ or placebo will be administrated intravenously as a 30-minute injection
Locations (18)
University Hospital
Amiens, France
University Hospital
Angers, France
University Hospital
Besançon, France
Pellegrin Hospital
Bordeaux, France
Morvan Hospital
Brest, France
University Hospital
Grenoble, France
Jeanne de Flandre Hospital
Lille, France
Mother and Child Hospital
Limoges, France
Women, Mother and Child Hospital
Lyon, France
La Timone Hospital
Marseille, France
University Hospital
Montpellier, France
Mother and Child Hospital
Nantes, France
Robert Debré Hospital
Paris, France
Trousseau Hospital
Paris, France
Necker Hospital
Paris, France
Anne de Bretagne University Hospital
Rennes, France
Purpan Children Hospital
Toulouse, France
Clocheville Hospital
Tours, France