Clinical trial

Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020

Name

V01-19052020

Description

The objective of this national, prospective, multi-centre observational study is to describe the prescription rational and practice in Germany, confirm the efficacy of caplacizumab in a real-world setting, and identify predicting factors in iTTP-patients with regard to persistent autoimmune activity, therapy guidance and risk of complications. The rational is to develop new treatment algorithms that optimize overall patient outcome and reduce treatment cost.

Trial arms

Trial start

2021-03-25

Estimated PCD

2024-10-01

Trial end

2025-03-01

Status

Recruiting

Treatment

Cablivi®

Intervention with Cablivi® take place outside of the study

Arms:

Registergroup

Size

350

Primary endpoint

Treatment of aTTP with caplacizumab

Enrollment

Eligibility criteria

Inclusion Criteria: * Confirmed diagnosis of an acute episode of acquired thrombotic thrombocytopenic purpura * Treatment with at least one single dose of caplacizumab (10 mg i.v. or s.c.) * Male or female patients ≥ 18 years of age * signed written informed consent Exclusion Criteria: * Hereditary thrombotic thrombocytopenic purpura * disability to give informed consent

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}

Updated at

2024-05-08

1 organization

1 product

1 indication

Organization

University of Cologne

Product

Cablivi®

Indication

Thrombotic thrombocytopenic purpura