NCT03131219

Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)

A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Atypical Hemolytic Uremic Syndrome (aHUS)

Interventions

Type	Name	Description
BIOLOGICAL	Ravulizumab	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.

Timeline

• Start date: 2017-08-31
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2017-04-27
• Last updated: 2024-03-15
• Results posted: 2020-09-16

Locations

18 sites across 7 countries: United States, Belgium, Germany, Italy, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study