CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Eculizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01193348
NCT01193348Phase 2Completed

An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome

Alexion Pharmaceuticals, Inc.·interventional·Posted Sep 1, 2010·Updated Apr 29, 2015

In Brief

A Phase 2 clinical trial evaluating Eculizumab for Atypical Hemolytic-Uremic Syndrome. Completed, enrolled 22 participants across 17 sites in 9 countries.

Detailed Summary

The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, France, Germany, Italy, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.8 years ago

Interventions

Eculizumabdrug

Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.