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COMPLETED
NCT02205541
PHASE3

Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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