At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 23 enrolled
Drug / intervention
Pegcetacoplandrug
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 Ib, Open Label, Multiple Ascending Dose, Pilot Study to Assess the Safety, Preliminary Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
In Brief
A Phase 1 clinical trial evaluating Pegcetacoplan for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 23 participants across 7 sites in 4 countries.
Detailed Summary
The objectives of the study are to assess the safety, tolerability, preliminary efficacy and PK of multiple subcutaneous (SC) doses of pegcetacoplan in subjects with paroxysmal nocturnal hemoglobinuria (PNH) who have not received treatment with eculizumab in the past. An exploratory objective of the study is to assess the pharmacodynamics (PD) of multiple SC doses of pegcetacoplan when administered to PNH patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesHong Kong, Malaysia, New Zealand, Thailand
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartDec 2015
Primary CompletionAug 2019
TodayJul 2026
First PostedOct 28, 2015
Enrollment StartDec 1, 2015
Primary CompletionAug 26, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.7 years ago
Interventions
Pegcetacoplandrug
Complement (C3) Inhibitor