AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME
Phase 1
- Conditions
- Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS)MedDRA version: 12.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndrome
- Registration Number
- EUCTR2010-020326-18-FR
- Lead Sponsor
- ALEXION PHARMACEUTICALS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 41
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
1. Chronic dialysis.
2. Prior eculizumab use, hypersensitivity to eculizumab, to murine proteins or to
one of the excipients.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method