At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 137 enrolled / 137 target
Drug / intervention
Pegcetacoplandrug
Likely dose
1,080mgfrom 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, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
In Brief
A Phase 3 clinical trial evaluating Pegcetacoplan for PNH. Completed, enrolled 137 participants across 62 sites in 21 countries.
Signals
Enrolling slower than its timeline implies
Detailed Summary
This is an Open-label, Non-Randomized, Multi-Center Extension Study. Eligible subjects will have previously completed a pegcetacoplan study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPNH
CountriesAustralia, Belgium, Bulgaria, Canada, Colombia, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Peru, Philippines, Russia, Serbia, Singapore, South Korea, Spain, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartAug 2018
Primary CompletionSep 2025
Study CompletionMay 2026
TodayJul 2026
First PostedMay 21, 2018
Enrollment StartAug 27, 2018
Primary CompletionSep 4, 2025
Study CompletionMay 19, 2026
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 8.1 years ago
Arms & Interventions
1,080 mg pegcetacoplan administered subcutaneouslyexperimental
1,080mg pegcetacoplan administered subcutaneously twice weekly or every three days.
Drug: Pegcetacoplan
Interventions
Pegcetacoplandrug
Complement (C3) Inhibitor