Caplacizumab

DRUG9 trials

Sponsors

Ablynx, a Sanofi company, Sanofi, University Hospital, Rouen, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, US Thrombotic Microangiopathy Alliance

Conditions

Acquired Thrombotic Thrombocytopenic PurpuraHealthy VolunteersImmune Thrombotic ThrombocytopeniaImmune-mediated Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic Purpura, Acquired

Phase 1

Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

CompletedNCT02189733

Ablynx, a Sanofi companyHealthy Volunteers

Start: 2014-07-31Updated: 2014-11-14

Phase 2

Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

CompletedNCT01151423

Ablynx, a Sanofi companyAcquired Thrombotic Thrombocytopenic Purpura

Start: 2011-01-31End: 2014-03-31Updated: 2023-04-04

Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTP

TerminatedNCT04720261

University Hospital, RouenThrombotic Thrombocytopenic Purpura, Acquired

Start: 2021-04-26End: 2023-05-16Updated: 2026-02-20

Phase 3

Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura

CompletedNCT02553317

Ablynx, a Sanofi companyAcquired Thrombotic Thrombocytopenic Purpura

Start: 2015-11-30End: 2017-08-31Updated: 2023-04-05

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

CompletedNCT02878603

SanofiAcquired Thrombotic Thrombocytopenic Purpura

Start: 2016-10-06End: 2020-10-23Updated: 2022-03-28

Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

CompletedNCT05468320

SanofiThrombotic Thrombocytopenic Purpura

Start: 2022-11-21End: 2024-12-26Updated: 2025-12-30

Unknown Phase

Retrospective Study on Caplacizumab-treated Pediatric Patients With Immune-mediated Thrombocytopenic Purpura (iTTP)

CompletedNCT05263193

SanofiImmune-mediated Thrombocytopenic Purpura

Start: 2022-06-08End: 2022-10-28Updated: 2022-12-14

A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI)

Fondazione Policlinico Universitario Agostino Gemelli IRCCSThrombotic Thrombocytopenic Purpura

Start: 2021-10-21End: 2023-03-30Target: 1Updated: 2023-03-27

Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors

Not yet recruitingNCT06358703

US Thrombotic Microangiopathy AllianceImmune Thrombotic Thrombocytopenia

Start: 2024-12-31End: 2028-05-31Target: 116Updated: 2024-11-13

Related Papers

Pharmacodynamics of Caplacizumab in Healthy Volunteers and Phase 2/3 Trial Patients with Immune-mediated Thrombotic Thrombocytopenic Purpura

Thrombosis and Haemostasis2026-07-15

Tailored treatment of acute immune-mediated thrombotic thrombocytopenic purpura.

2025-12-01

Caplacizumab improves clinical outcomes and is well tolerated across clinically relevant subgroups of patients with immune-mediated thrombotic thrombocytopenic purpura.

2024-07-151 citations

Cost-Effectiveness of Caplacizumab in the Warranty Program in Immune Thrombotic Thrombocytopenic Purpura in the USA

Blood2023-11-02

A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAPLACIZUMAB WITHOUT FIRST-LINE THERAPEUTIC PLASMA EXCHANGE IN ADULTS WITH IMMUNE-MEDIATED THROMBOTIC THROMBOCYTOPENIC PURPURA

Hematology Transfusion and Cell Therapy2023-10-01

The Role of ADAMTS13 Activity Levels on Disease Exacerbation or Relapse in Patients with Immune-Mediated Thrombotic Thrombocytopenic Purpura: Post Hoc Analysis of the Phase 3 HERCULES and Post-HERCULES Studies

Blood2022-11-151 citations

A Phase 3 Study to Evaluate the Efficacy and Safety of Caplacizumab without First-Line Therapeutic Plasma Exchange in Adults with Immune-Mediated Thrombotic Thrombocytopenic Purpura

Blood2022-11-15

Long-term follow-up of patients treated with caplacizumab and safety and efficacy of repeat caplacizumab use: Post-HERCULES study.

2022-10-2128 citations

LONG-TERM OUTCOMES OF PATIENTS TREATED WITH CAPLACIZUMAB FOR IMMUNE-MEDIATED THROMBOTIC THROMBOCYTOPENIC PURPURA (ITTP): THE POST-HERCULES STUDY

Hematology Transfusion and Cell Therapy2022-10-01

S294: LONG-TERM SAFETY AND EFFICACY OF CAPLACIZUMAB FOR ACQUIRED THROMBOTIC THROMBOCYTOPENIC PURPURA (ATTP): THE POST-HERCULES STUDY

HemaSphere2022-06-01

Long-Term Safety and Efficacy of Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura (aTTP): The Post-HERCULES Study

Blood2021-11-052 citations

Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis

Blood Advances2021-04-2177 citations

Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study.

2019-12-0938 citations

Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura

New England Journal of Medicine2019-01-09956 citations

Results of the Randomized, Double-Blind, Placebo-Controlled, Phase 3 Hercules Study of Caplacizumab in Patients with Acquired Thrombotic Thrombocytopenic Purpura

Blood2017-12-0719 citations

Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura

New England Journal of Medicine2016-02-11639 citations