An Open-label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients with Atypical Hemolytic-Uremic Syndrome
- Conditions
- atypical hemolytic-uremic syndrome100291491001891110027665
- Registration Number
- NL-OMON34260
- Lead Sponsor
- Alexion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 2
1. Patient*s parent/legal guardian must be willing and able to give written informed consent and the patient must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)].
2. Pediatric patients with aHUS. Patients may be newly diagnosed, or with previously diagnosed disease, or post-kidney transplant with the disease.
3. Patients from 1 month up to 18 years of age and body weight >= 5 kg.
4. Patients exhibit Thrombocytopenia, hemolysis and elevated Serum Creatinine.
1. Plasma Therapy for > 5 weeks prior to enrollment.
2. Chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy for end stage renal disease).
3. Prior eculizumab use or hypersensitivity to eculizumab, to murine proteins or to one of the excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy and safety.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy.</p><br>