Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP

Acquired Thrombotic Thrombocytopenic Purpura Clinical Trial

— REACT-2020  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985318
• Other study ID #: V01-19052020
• Status: Recruiting
• Start date: March 25, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: University of Cologne
• Contact: Linus Völker, MD
• Phone: +49 221 478 86285
• Email: linus.voelker[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Thrombotic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic

Intervention

Drug:
• Cablivi®
Intervention with Cablivi® take place outside of the study

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment of aTTP with caplacizumab	Description of the prescription rationale and practice of caplacizumab in the treatment of aTTP	Enrollment
Secondary	Stabilization of thrombocyte	Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of stabilization of thrombocyte. Thrombocyte stabilization is defined as thrombocyte > 150 x 10E9/L	Enrollment
Secondary	Normalization of LDH	Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of normalization of Lactate dehydrogenase (LDH). Normalization of LDH is defined as LDH below upper limit of normal	Enrollment
Secondary	Normalization of haptoglobin	Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of normalization of haptoglobin. Normalization of haptoglobin is defined as haptoglobin above lower limit of normal	Enrollment
Secondary	Risk factors for complications	Identification of risk factors for complications	Enrollment
Secondary	Risk factors for adverse outcomes	Identification of risk factors for adverse outcomes	Enrollment
Secondary	Risk factors for persistent autoimmune activity	Identification of risk factors for persistent autoimmune activity	Enrollment
Secondary	Parameters for therapy guidance	Identification of parameters that guide duration and regimen of caplacizumab treatment	Enrollment
Secondary	Effect of caplacizumab on adjunct treatments with PEX	Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of therapeutic plasma exchange therapy (PEX)	Enrollment
Secondary	Effect of caplacizumab on adjunct treatments	Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of glucocorticoids	Enrollment