At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 104 enrolled
Drug / intervention
Caplacizumab +1 morebiological
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.
Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)
In Brief
A Phase 3 clinical trial evaluating Caplacizumab and Standard of Care for Acquired Thrombotic Thrombocytopenic Purpura. Completed, enrolled 104 participants across 45 sites in 13 countries.
Detailed Summary
The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Canada, Czechia, France, Hungary, Israel, Italy, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartOct 2016
Primary CompletionOct 2020
TodayJul 2026
First PostedAug 25, 2016
Enrollment StartOct 6, 2016
Primary CompletionOct 23, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.9 years ago
Interventions
Caplacizumabbiological
Standard of Careother
• PE with plasma (e.g., fresh frozen plasma, solvent detergent/viral-inactivated plasma, cryosupernatant), • Corticosteroid treatment and • Use of other immunosuppressive agents (e.g., rituximab).