CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 7 enrolled
Drug / intervention
Eculizumabdrug
Likely dose
Eculizumab 5 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/NCT00867932
NCT00867932Phase 4Completed
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An Open-Label Multi-Center Study of Eculizumab in Children and Adolescents With a Diagnosis of Paroxysmal Nocturnal Hemoglobinuria

Alexion Pharmaceuticals, Inc.·interventional·Posted Mar 24, 2009·Updated Oct 31, 2018

In Brief

A Phase 4 clinical trial evaluating Eculizumab for Hemoglobinuria, Paroxysmal. Completed, enrolled 7 participants across 3 sites.

Detailed Summary

The primary objective of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for pediatric and adolescent participants with PNH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemoglobinuria, Paroxysmal
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 24, 2009
Enrollment StartOct 2, 2009
Primary CompletionMay 12, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.3 years ago

Interventions

Eculizumabdrug

5 mg/mL solution in 5% Dextrose