At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 13 enrolled
Drug / intervention
Ravulizumabbiological
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.
A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)
In Brief
A Phase 3 clinical trial evaluating Ravulizumab for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 13 participants across 9 sites in 6 countries.
Detailed Summary
The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesFrance, Netherlands, Norway, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartFeb 2018
Primary CompletionMar 2020
Study CompletionAug 2022
TodayJul 2026
First PostedJan 23, 2018
Enrollment StartFeb 22, 2018
Primary CompletionMar 25, 2020
Study CompletionAug 25, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.4 years ago
Interventions
Ravulizumabbiological
Single intravenous (IV) loading dose on Day 1, followed by regular IV maintenance dosing beginning on Day 15, based on weight.