臨床研究等提出・公開システム

Japanese

Date of registration	May. 10, 2024
Last modified on	Mar. 28, 2025
Trial ID	jRCT1030240076

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

Contact for Scientific Queries	Name	Ioka Akiko
	Affiliation	Chugai Pharmaceutical Co., Ltd.
	Address	2-1-1, Nihonbashi Muromachi, Chuo-ku,Tokyo,Japan
	Telephone	+81-3-3273-0866
	E-mail	ioka.akiko08@chugai-pharm.co.jp
Contact for Public Queries	Name	Ito Takahiro
	Affiliation	Chugai Pharmaceutical Co., Ltd.
	Address	2-1-1, Nihonbashi Muromachi, Chuo-ku,Tokyo,Japan
	Telephone	+81-3-3273-0866
	E-mail	itotkh@chugai-pharm.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 10, 2024
Actual date of first enrollment		July. 08, 2024
Target sample size		100
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects will be included in the study if they meet all of the following items. 1) 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) 2) 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.
	Exclusion Criteria	Study subjects who fall under any of the following items will be excluded from the study: 1) Patients with concomitant systemic diseases (e.g., rheumatoid arthritis) with joint involvement 2) Patients with other bleeding disorders other than congenital hemophilia A 3) 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. 4) Subjects whose MRI is judged to be difficult to perform by the study director or study co-workers 5) Patients with difficulties in using electronic patient-reported outcomes (electronic patient-reported outcome:ePRO) (patients or caregivers) 6) Patients who are participating in clinical research involving clinical trials or interventions (including planned participation) 7) Patients who are judged to be inappropriately participating in the study by the research director or research subinvestigator at the participating medical institution.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Congenital hemophilia A
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Assessment of fluid collection (joint fluid/blood), synovial thickening, cartilaginous degeneration, and bone degeneration based on the central assessment of US images (foot, knee, and elbow).
Secondary Outcome(s)		Assessment of fluid retention, synovial thickening, cartilaginous degeneration, and bone degeneration based on the central assessment of MRI images (foot, knee, and elbow).

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor	Chugai Pharmaceutical Co., Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Non-Profit Organization MINS Research Etthics Committee
Address	5-20-9-401, Mita, Minato-ku, Tokyo,Japan, Tokyo
Telephone	+81-3-6416-1868
E-Mail	npo-mins@j-irb.com
Approval Status	Approval
Date of approval

Name of Certified Review Board	The Tokushukai Group Ethics Committee
Address	Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan, Tokyo
Telephone	+81-3-3263-4801
E-Mail	mirai-ec1@mirai-iryo.com
Approval Status	Approval
Date of approval

Name of Certified Review Board	Ethics Committee Tohoku University Graduate School of Medicine
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan, Tokyo
Telephone	+81-22-717-8007
E-Mail	med-kenkyo@grp.tohoku.ac.jp
Approval Status	Approval
Date of approval

Name of Certified Review Board	the Clinical Research Ethics Review Committee of Mie University Hospital
Address	2-174 Edobashi Tsu city, Mie 514-8507, Japan , Tokyo
Telephone	+81-59-231-5045
E-Mail	mie-crb@mo.medic.mie-u.ac.jp
Approval Status	Approval
Date of approval

Name of Certified Review Board	Medical Corporation Foundation Ogikubo Hospital Ethics Committee
Address	3-1-24 Imagawa, Suginami-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-3399-1101
E-Mail
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Mar. 28, 2025	(this page)	Changes
4	Dec. 13, 2024	Detail	Changes
3	Dec. 05, 2024	Detail	Changes
2	Oct. 16, 2024	Detail	Changes
1	May. 10, 2024	Detail

List of change history