Clinical Trial: A single-center retrospective study on clinical outcomes after the introduction of caplacizumab for thrombotic thrombocytopenic purpura and an exploratory analysis of risk factors for the ADAMTS13 inhibitor boosting (Japan)

Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062446) titled 'A single-center retrospective study on clinical outcomes after the introduction of caplacizumab for thrombotic thrombocytopenic purpura and an exploratory analysis of risk factors for the ADAMTS13 inhibitor boosting' on Aug. 3.

Study Type: Observational

Primary Sponsor: Institute - Department of Hematology and Oncology, Graduate School of Medicine, Mie University

Condition: Condition - Thrombotic thrombocytopenic purpura Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to comprehensively characterize the clinical characteristics, treatment strategies, and clinical outcomes of patients with thrombotic thrombocytopenic purpura (TTP) diagnosed at our institution between 2014 and 2025. Furthermore, we aim to compare patients treated before and after the introduction of caplacizumab and to exploratorily identify risk factors associated with ADAMTS13 inhibitor boosting under contemporary treatment strategies. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Participants must meet all of the following inclusion criteria: Patients newly diagnosed with thrombotic thrombocytopenic purpura (TTP) at our institution. Patients for whom baseline demographic and clinical information can be confirmed from the medical records. Key exclusion criteria - Patients meeting one or more of the following exclusion criteria will be excluded from the study: Patients for whom the diagnosis of thrombotic thrombocytopenic purpura (TTP) is considered uncertain based on the available diagnostic data. Patients who declined participation through the opt-out procedure. Target Size - 12

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 04 Month 13 Day Date of IRB - 2026 Year 05 Month 07 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070680

Disclaimer: Curated by HT Syndication.