臨床研究等提出・公開システム

Date of registration	June. 11, 2020
Last modified on	July. 20, 2023
Trial ID	jRCT2080225225

Scientific Title	A Phase II, long-term, extension study of DS-5141b in Patients With Duchenne Muscular Dystrophy
Public Title	A Phase II, long-term, extension study of DS-5141b in Patients With Duchenne Muscular Dystrophy

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Phone Number	+81-3-6225-1111
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Phone Number	+81-3-6225-1111
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		June. 30, 2020
Target Sample Size		8
Study Type		Interventional
Study Design	Study Design	multi-center, open-label extension
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Has competed a study of DS5141-A-J101.
	Exclusion Criteria	1) Significant safety issues in a study of DS5141-A-J101 2) Patient who does not consent to use appropriate contraception 3) Patient who was judged by the investigator that is not appropriate to participate in this study
	Minimum Age	5age old over
	Maximum Age	No limit
	Gender	Male
Health Condition or Problem Studied		Duchenne muscular dystrophy
Intervention(s)		investigational material(s) Generic name etc : DS-5141b INN of investigational material : renadirsen Therapeutic category code : 49- Other agents affecting cellular function Dosage and Administration for Investigational material : 2.0 mg/kg or 6.0 mg/kg, of DS-5141b will be administered subcutaneously once a week control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy <Safety> Adverse events, Laboratory tests, etc. <Efficacy> Motor function, Respiratory function, Cardiac function, Quantitative muscle strength evaluation
Secondary Outcome		pharmacokinetics plasma concentration of DS-5141a

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Kobe University Hospital Institutional Review Board
Address of IRB	7-5-2 Kusunokicho, Kobe Chuo-ku, Hyogo, 650-0017, Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	April. 27, 2020

Secondary ID No.	NCT04433234
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-205321
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
8	July. 20, 2023	(this page)	Changes
7	April. 16, 2023	Detail	Changes
6	Mar. 02, 2022	Detail	Changes
5	Jan. 26, 2022	Detail	Changes
4	Aug. 19, 2021	Detail	Changes
3	July. 31, 2020	Detail	Changes
2	July. 03, 2020	Detail	Changes
1	June. 11, 2020	Detail

List of change history