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.
Study Type
OBSERVATIONAL
Enrollment
350
Intervention with Cablivi® take place outside of the study
University Hospital of Cologne
Cologne, Germany
RECRUITINGTreatment of aTTP with caplacizumab
Description of the prescription rationale and practice of caplacizumab in the treatment of aTTP
Time frame: Enrollment
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
Time frame: Enrollment
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
Time frame: Enrollment
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
Time frame: Enrollment
Risk factors for complications
Identification of risk factors for complications
Time frame: Enrollment
Risk factors for adverse outcomes
Identification of risk factors for adverse outcomes
Time frame: Enrollment
Risk factors for persistent autoimmune activity
Identification of risk factors for persistent autoimmune activity
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Time frame: Enrollment
Parameters for therapy guidance
Identification of parameters that guide duration and regimen of caplacizumab treatment
Time frame: Enrollment
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)
Time frame: Enrollment
Effect of caplacizumab on adjunct treatments
Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of glucocorticoids
Time frame: Enrollment