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June. 11, 2020

July. 20, 2023

jRCT2080225225

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

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

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

completed

June. 30, 2020

8

Interventional

multi-center, open-label extension

treatment purpose

2

Has competed a study of DS5141-A-J101.

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

5age old over
No limit

Male

Duchenne muscular dystrophy

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 : -

safety
efficacy
<Safety>
Adverse events, Laboratory tests, etc.

<Efficacy>
Motor function, Respiratory function, Cardiac function, Quantitative muscle strength evaluation

pharmacokinetics
plasma concentration of DS-5141a

DAIICHI SANKYO Co.,Ltd.
-
-
-
Kobe University Hospital Institutional Review Board
7-5-2 Kusunokicho, Kobe Chuo-ku, Hyogo, 650-0017, Japan

approved

April. 27, 2020

NCT04433234
ClinicalTrials.gov
JapicCTI-205321
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