9 completed, 1 active not recruiting, 1 not yet recruiting, 1 terminated. 4 Phase 2, 4 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Phase 3 | 4 | Completed 4 |
| Phase 1 | 1 | Completed 1 |
Follow caplacizumab: new trials by email Literature Review of caplacizumab trials Research Report on caplacizumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors Caplacizumab - Immune Thrombotic Thrombocytopenia | Not yet recruiting | US Thrombotic Microangiopathy Alliance | 116 | 2024-12-01 | 2024-11-13 | |
| Platelet Response to Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura Cablivi - Acquired Thrombotic Thrombocytopenic Purpura | Completed | University of Cologne | 223 | 2023-10-30 | 2025-09-12 | |
| Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura Caplacizumab, Corticosteroids, anti-CD20 antibody - Thrombotic Thrombocytopenic Purpura | Phase 3 | Completed | Sanofi | 51 | 2022-11-21 | 2025-12-30 |
| Retrospective Study on Caplacizumab-treated Pediatric Patients With Immune-mediated Thrombocytopenic Purpura (iTTP) Caplacizumab - Immune-mediated Thrombocytopenic Purpura | Completed | Sanofi | 4 | 2022-06-08 | 2022-12-14 | |
| A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI) Caplacizumab - Thrombotic Thrombocytopenic Purpura | Unknown | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 1 | 2021-10-21 | 2023-03-27 | |
| Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTP Caplacizumab - Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | Terminated | University Hospital, Rouen | 58 | 2021-04-26 | 2026-02-20 |
| Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP Cablivi® - Acquired Thrombotic Thrombocytopenic Purpura | Active not recruiting | University of Cologne | 350 | 2021-03-25 | 2026-04-30 | |
| A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Caplacizumab (ALX-0081), Plasma exchange (PE), Corticosteroid treatment (Methylprednisolone or prednisolone) - Thrombotic Thrombocytopenic Purpura | Phase 2 / Phase 3 | Completed | Sanofi | 21 | 2019-10-21 | 2025-09-22 |
| Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES) Caplacizumab, Standard of Care - Acquired Thrombotic Thrombocytopenic Purpura | Phase 3 | Completed | Sanofi | 104 | 2016-10-06 | 2022-03-28 |
| Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura Caplacizumab, Placebo - Acquired Thrombotic Thrombocytopenic Purpura | Phase 3 | Completed | Ablynx, a Sanofi company | 145 | 2015-11-01 | 2023-04-05 |
| Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab. Caplacizumab - Healthy Volunteers | Phase 1 | Completed | Ablynx, a Sanofi company | 24 | 2014-07-01 | 2014-11-14 |
| Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Caplacizumab, Placebo - Acquired Thrombotic Thrombocytopenic Purpura | Phase 2 | Completed | Ablynx, a Sanofi company | 75 | 2011-01-01 | 2023-04-04 |
| Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients ALX-0081, ReoPro® - Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI) | Phase 2 | Completed | Ablynx, a Sanofi company | 364 | 2009-09-01 | 2023-04-04 |
Purpura, Thrombotic Thrombocytopenic (8) · Angina, Stable (1) · Angina, Unstable (1) · Cognitive Dysfunction (1) · Non-ST Elevated Myocardial Infarction (1) · Thrombotic thrombocytopenic purpura, acquired (1)
Ablynx, a Sanofi company (4) · Sanofi (4) · University of Cologne (2) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (1) · US Thrombotic Microangiopathy Alliance (1) · University Hospital, Rouen (1)
France (6) · Germany (6) · Belgium (5) · Italy (5) · United Kingdom (5) · United States (5) · Austria (4) · Czechia (4) · Israel (4) · Spain (4) · Switzerland (4) · Canada (3) · Australia (2) · Hungary (2) · Japan (2)
Jean-Michel Paillarse, MD (1) · Josefin-Beate Holz, MD (1)
PMID 33881463, PMID 22475545, PMID 26863353, PMID 30625070, PMID 31691462, PMID 36138517, PMID 36427162, PMID 36696206, PMID 39095866, PMID 41159657, PMID 41348038
2014 (1), 2015 (1), 2016 (1)