An open-label, multi-center clinical trial of eculizumab in pediatric patients with atypical hemolytic-uremic syndrome (aHUS) - ND

• Conditions: Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS); MedDRA version: 9.1Level: LLTClassification code 10019515

• Registration Number: EUCTR2010-020310-28-IT
• Lead Sponsor: ALEXION PHARMACEUTICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-03
• Last Update Posted: 19 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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. For the complete list of inclusion criteria please refer to the Protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known familial ADAMTS13 deficiency (ADAMTS-13 <5%). 2. Typical HUS (known Shiga toxin +). 3. History of malignancy within 5 years of screening. For the complete list of exclusion criteria please refer to the Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified