At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
ALXN1210biological
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.
An Open-Label, Intrapatient, Dose-Escalation Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria
In Brief
A Phase 2 clinical trial evaluating ALXN1210 for PNH. Completed, enrolled 13 participants across 8 sites in 2 countries.
Detailed Summary
This study evaluated the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple intravenous (IV) doses of ALXN1210 administered to participants with PNH who have not previously been treated with complement inhibitor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPNH
CountriesAustralia, South Korea
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartNov 2015
Primary CompletionJul 2016
Study CompletionMar 2021
TodayJul 2026
First PostedNov 6, 2015
Enrollment StartNov 12, 2015
Primary CompletionJul 14, 2016
Study CompletionMar 11, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.7 years ago
Interventions
ALXN1210biological
Participants were administered ravulizumab as an IV infusion every 4 weeks.