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

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

June 30, 2018

Study Completion Date

June 30, 2018

Conditions
Hemolytic Uremic Syndrome of Childhood
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"

Trial Locations (18)

25030

University Hospital, Besançon

29609

Morvan Hospital, Brest

31059

Purpan Children Hospital, Toulouse

33000

Pellegrin Hospital, Bordeaux

34295

University Hospital, Montpellier

35056

Anne de Bretagne University Hospital, Rennes

37044

Clocheville Hospital, Tours

44000

Mother and Child Hospital, Nantes

49100

University Hospital, Angers

59037

Jeanne de Flandre Hospital, Lille

60107

University Hospital, Grenoble

69500

Women, Mother and Child Hospital, Lyon

75019

Robert Debré Hospital, Paris

75571

Trousseau Hospital, Paris

75743

Necker Hospital, Paris

80054

University Hospital, Amiens

87000

Mother and Child Hospital, Limoges

Unknown

La Timone Hospital, Marseille

All Listed Sponsors
lead

University Hospital, Toulouse

OTHER

NCT02205541 - Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU | Biotech Hunter | Biotech Hunter