At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 9 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.
An Open Label, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL-2 as an Add-On to Standard of Care in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH).
In Brief
A Phase 1 clinical trial evaluating Pegcetacoplan for Paroxysmal Nocturnal Hemoglobinuria (PNH). Completed, enrolled 9 participants across 7 sites.
Detailed Summary
This study will be the initial exploration of pegcetacoplan in patients with PNH. The assessments of the safety, tolerability, PK, and PD following administration of single and multiples doses of pegcetacoplan will guide decisions to further develop the drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartFeb 2015
Primary CompletionOct 2018
TodayJul 2026
First PostedOct 15, 2014
Enrollment StartFeb 23, 2015
Primary CompletionOct 22, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.7 years ago
Interventions
Pegcetacoplandrug
Complement (C3) Inhibitor