Thrombotic Thrombocytopenic Purpura Clinical Trial
Official title:
An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura
Primary Objective: To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period. Secondary Objectives: - To evaluate effect of caplacizumab on - prevention of recurrence of TTP (the number of recurrences of TTP) during overall study period. - a composite endpoint consisting of aTTP-related mortality, recurrence of aTTP and major thromboembolic events during study drug treatment - restoring platelet counts as a measure of prevention of further microvascular thrombosis - refractory disease - biomarkers of organ damage: LDH, cardiac troponin I, serum creatinine - plasma exchange (PE) parameters (days of PE and volume of plasma used), days in intensive care unit, days in hospital - cognitive status of Japanese patients - To evaluate safety profile of caplacizumab in Japanese patients - To evaluate effect of caplacizumab on pharmacodynamic (PD) markers in Japanese patients - To evaluate pharmacokinetic (PK) profile of caplacizumab in Japanese patients - To evaluate immunogenicity of caplacizumab in Japanese patients
Study duration per participant is approximately 2 months up to approximately 6 months in case of treatment extension and recurrence during the study drug treatment period. ;
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