NCT04419233Completed
Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection
A Multicenter, Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection When Used in Routine Medical Practice in China
Source: ClinicalTrials.gov · Last updated 7 Dec 2023
Brief summary (registry, in English)
The primary objective of this study is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in China.The secondary objectives are to collect data on the efficacy and the pharmacokinetics of nusinersen sodium injection in the post-marketing setting in China.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 3 Jun 2020
- Start date
- 18 Nov 2020
- Primary completion date
- 21 Nov 2023
- Lead sponsor
- Biogen
- Diseases
- Spinal muscular atrophy
- NCT number
- NCT04419233
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 18 Nov 2020 to the primary completion date, 21 Nov 2023
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Hypersensitivity to the active substance or any of the excipients of nusinersen sodium injection.
- Current or past administration of nusinersen sodium injection, in either a commercial or a clinical study setting.
Other
- Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Ability of the participant or his/her legally authorized representative (e.g., parent or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
- The decision to newly prescribe nusinersen sodium injection according to the local marketing authorization, including documentation of 5q SMA diagnosis, has been made by the Investigator and agreed to by the participant (or legally authorized representative)
Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Minhang | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Xicheng | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.