At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 24 enrolled
Drug / intervention
Pegcetacoplan +1 moredrug
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, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
In Brief
A Phase 3 clinical trial evaluating Pegcetacoplan and Placebo matching Pegcetacoplan for Cold Agglutinin Disease. Completed, enrolled 24 participants across 44 sites in 14 countries.
Detailed Summary
The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin disease (CAD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCold Agglutinin Disease
CountriesAustria, Belgium, Canada, Finland, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Norway, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartOct 2022
Primary CompletionMay 2024
Study CompletionSep 2024
TodayJul 2026
First PostedOct 27, 2021
Enrollment StartOct 20, 2022
Primary CompletionMay 27, 2024
Study CompletionSep 11, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.7 years ago
Interventions
Pegcetacoplandrug
Pegcetacoplan taken twice weekly as subcutaneous injection
Placebo matching Pegcetacoplandrug
Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection