Shiga-Toxin producing Escherichia Coli Hemolytic-Uremic Syndrome MedDRA version: 14.0 Level: LLT Classification code 10019515 Term: Hemolytic uremic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Sponsors
ALEXION PHARMA INTERNATIONAL SARL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients and/or legal guardian must be willing and able to give written informed consent 2. Adults, adolescents or pediatrics (= 2 month and = 5kg) patients 3. Shiga-Toxin producing Escherichia Coli Hemolytic-Uremic Syndrome 4. Venous or Arterial Thrombosis plausibly related to the EHEC event Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Unresolved systemic meningococcal disease 2. Any medical or psychological condition that in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study. 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients 4. Use of other experimental medicine / inclusion in other investigational intervention studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and Efficacy of treatment with eculizumab in patients with STEC-HUS;Secondary Objective: Safety and Efficacy of treatment with eculizumab in patients with STEC-HUS;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and efficacy;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Countries
Germany
Contacts
Public ContactEuropean Clinical Trial Information
ALEXION EUROPE SAS
Outcome results
None listed