Jiang, Yuwu
Wang, Yi
Xiong, Hui
Li, Wenhui
Luo, Rong
Chen, Wenxiong
Yin, Fei
Lü, Junlan
Liang, Jianmin
Chen, Wan-Jin
Lu, Xinguo
Wang, Hua
Tang, Jihong
Monine, Michael
Makepeace, Corinne
Jin, Xin
Foster, Richard
Chin, Russell
Berger, Zdenek
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Post-Marketing Surveillance Study of Nusinersen for Spinal Muscular Atrophy in Routine Medical Practice in China: Interim Results
https://doi.org/10.1007/s12325-024-02852-7
Funding for this research was provided by:
Biogen
Article History
Received: 20 November 2023
Accepted: 21 March 2024
First Online: 9 May 2024
Declarations
:
: Yuwu Jiang, Yi Wang, Hui Xiong, Wenhui Li, Rong Luo, Wenxiong Chen, Fei Yin, Junlan Lü, Jianmin Liang, Wan-Jin Chen, Xinguo Lu, Hua Wang, and Jihong Tang: nothing to disclose. Michael Monine, Corinne Makepeace, Richard Foster, Zdenek Berger: employees of Biogen and may hold stock in the company. Xin Jin: employee of Cytel at the time of development. Russell Chin: employee of Biogen at the time of development.
: This study was performed in accordance with Title 21, United States Code of Federal Regulations (CFR) Parts 50, 54, 56 and 312 Subpart D; the International Council for Harmonisation Guideline on GCP (E6); the European Union Clinical Trial Directive 2001/20/EC or Clinical Trial Regulation 536/2014; and the ethical principles outlined in the Declaration of Helsinki; and/or, where applicable, the European Directive 2001/20 in relation to GCP in the conduct of clinical trials on medicinal products for human use and Directive 2005/28 on GCP for investigational medicinal products for human use. Ethics committee approval of all study documents was obtained prior to the start of the study at the following sites that enrolled participants: EC of Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, China; Childrens Hospital of Fudan University, No. 399 Wanyuan Road, Minhang District, Shanghai, China; EC of Beijing Children's Hospital, No. 56 Nanlishi Road, Xicheng District, Beijing, China; EC of Shenzhen Children’s Hospital, No. 7019, Yitian Road, Shenzhen City, Guangdong Province, China; EC of Guangzhou Woman and Children's Medical Center, No. 9 Jinsui Road, Zhujiang New Town, Tianhe District, Guangzhou City, Guangdong Province, China; Medical Ethics Committee of Xiangya Hospital of Central South University, No. 87 Xiangya Road, Kaifu District, Changsha City, Hu'nan Province, China; EC of the First Affiliated Hospital of Fujian Medical University, No. 20 Chazhong Road, Fuzhou City, Fujian Province, China; EC of the First Hospital of Jilin University, No. 1 Xinmin Street, Changchun City, Jilin Province, China; Medical Ethics Committee of the Children's Hospital of Zhejiang University School of Medicine, No. 3333 Binsheng Road, Binjiang District, Hangzhou City, Zhejiang Province, China; EC of Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shengyang City, Liaoning Province, China; Clinical Trial Ethical Committee of West China Second Hospital, Sichuan University, No. 20 San Duan South Renmin Road, Chengdu City, Sichuan Province, China. Informed consent was obtained from all participants or their legally authorized representative in accordance with local practice and regulations.