Timely Assessment with Key Ultrasonography for Management and Individualized Intervention in Hemophilia Joints (TAKUMI study)

Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 100 人开始时间: 2024年7月8日最近更新: 2025年3月28日

试验速览

阶段: 不适用
状态: 招募中
发起方: Chugai Pharmaceutical Co., Ltd.
入组人数: 100
主要终点: Assessment of fluid collection

研究概览入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Observational

入排标准

年龄范围: No limit 至 No limit（—）
性别: All

入选标准

•Subjects will be included in the study if they meet all of the following items.
•Patients with congenital haemophilia A (any age, male or female) who are undergoing regular bleeding prophylaxis including emicizumab or who are scheduled to start by the start of observation (Week 0 visit)
•Patients who have received adequate explanation of the content of this study, and who have given written consent based on their own free will from the subjects of the study or their legally acceptable representative, and who are able to comply with the procedures of the study protocol.

排除标准

•Study subjects who fall under any of the following items will be excluded from the study:
•Patients with concomitant systemic diseases (e.g., rheumatoid arthritis) with joint involvement
•Patients with other bleeding disorders other than congenital hemophilia A
•Patients who are judged by the research director or research co-workers at the participating medical organization to have a significant range of motion restriction or prosthesis in 4 or more of the 6 joints of the left and right foot, knee, and elbow.
•Subjects whose MRI is judged to be difficult to perform by the study director or study co-workers
•Patients with difficulties in using electronic patient-reported outcomes (electronic patient-reported outcome:ePRO) (patients or caregivers)
•Patients who are participating in clinical research involving clinical trials or interventions (including planned participation)
•Patients who are judged to be inappropriately participating in the study by the research director or research subinvestigator at the participating medical institution.

结局指标

主要结局

Assessment of fluid collection

Assessment of fluid collection (joint fluid/blood) based on the central assessment of US images (foot, knee, and elbow).

Assessment of synovial thickening

Assessment of synovial thickening based on the central assessment of US images (foot, knee, and elbow).

Assessment of cartilaginous degeneration

Assessment of cartilaginous degeneration based on the central assessment of US images (foot, knee, and elbow).

Assessment of bone degeneration

Assessment of bone degeneration based on the central assessment of US images (foot, knee, and elbow).

次要结局

fluid retention
synovial thickening
cartilaginous degeneration
bone degeneration

研究者

发起方

Chugai Pharmaceutical Co., Ltd.

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