At a glance
ClinicalIndex Comparison Record- ✓Age birth to <18 years (naïve cohort) or 12 to <18 years (eculizumab-experienced cohort)
- ✓Body weight ≥5 kg at consent (naïve cohort)
- ✓Evidence of thrombotic microangiopathy (TMA): low platelet count, hemolysis, and decreased kidney function
- ✓No prior complement inhibitor therapy (naïve cohort)
- ✕ADAMTS13 deficiency (activity <5%)
- ✕Shiga toxin-related hemolytic uremic syndrome
- ✕Positive direct Coombs test
- ✕Pregnancy, planned pregnancy, or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)
In Brief
A Phase 3 clinical trial evaluating Ravulizumab for Atypical Hemolytic Uremic Syndrome (aHUS). Completed, enrolled 34 participants across 18 sites in 7 countries.
Detailed Summary
The purpose of the study is to assess the efficacy of ravulizumab to control disease activity in children and adolescents with aHUS who have not previously used a complement inhibitor (complement inhibitor treatment-naïve), as well as in complement inhibitor-experienced (eculizumab-experienced) adolescent participants.
Study Details
Timeline
Interventions
Participant received weight-based dosages for 26 weeks during the Initial Evaluation Period. Participants received a loading dose on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter for participants weighing ≥ 20 kg, or once every 4 weeks for participant weighing \< 20 kg.