NCT01194973

An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The record Primary purpose is to assess the efficacy of eculizumab in adult patients with Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as characterized by thrombocytopenia, hemolysis and renal impairment.

Conditions

• Atypical Hemolytic-Uremic Syndrome

Interventions

Type	Name	Description
DRUG	Eculizumab	All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-10-01
• Completion: 2014-02-01
• First posted: 2010-09-03
• Last updated: 2017-05-30
• Results posted: 2015-04-24

Locations

23 sites across 7 countries: United States, Belgium, France, Germany, Italy, Spain, United Kingdom