Clinical Trials Directory

Trials / Completed

CompletedNCT02878603

Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
104 (actual)
Sponsor
Sanofi · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BIOLOGICALCaplacizumab
OTHERStandard of Care• 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).

Timeline

Start date
2016-10-06
Primary completion
2020-10-23
Completion
2020-10-23
First posted
2016-08-25
Last updated
2022-03-28
Results posted
2021-11-22

Locations

45 sites across 13 countries: United States, Austria, Belgium, Canada, Czechia, France, Hungary, Israel, Italy, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Source: ClinicalTrials.gov record NCT02878603. Inclusion in this directory is not an endorsement.