Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 14.0 Level: LLT Classification code 10019515 Term: Hemolytic uremic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: SOLIRIS
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: eculizumab
Current Sponsor code: h5G1.1-mAb
Other descriptive name: Anti-C5 antibody
Concentration u
Sponsors
ALEXION PHARMACEUTICALS, INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must be willing and able to give written informed consent. 2. Patient’s age = 18 years. 3. Patients exhibit thrombocytopenia, hemolysis and elevated Serum creatinine Are the trial subjects under 18? no 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. Chronic dialysis 2. Prior eculizumab use, hypersensitivity to eculizumab, to murine proteins or to one of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy of eculizumab in adult patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.;Secondary Objective: Efficacy and Safety;Primary end point(s): Proportion of patients with complete TMA response | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed