CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1 enrolled
Drug / intervention
Eculizumabdrug
Likely dose
Eculizumab 900 mgfrom 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/NCT00844844
NCT00844844Phase 2Completed

An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)

Alexion Pharmaceuticals, Inc.·interventional·Posted Feb 16, 2009·Updated Jul 23, 2015

In Brief

A Phase 2 clinical trial evaluating Eculizumab for Atypical Hemolytic Uremic Syndrome. Completed, enrolled 1 participant across 17 sites in 5 countries.

Detailed Summary

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, France, Germany, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2009
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2010
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.4 years ago

Interventions

Eculizumabdrug

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.