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Long-term follow-up of patients with spinal muscular atrophy Treated with OAV101 IT or OAV101 IV in Clinical Trials
EU CTIS ID: 2024-511707-42-00
What this study is testing
The primary objective of this study is to assess long-term safety in terms of treatment-emergent serious adverse events (SAEs) and treatment-emergent adverse events of special interest (AESIs) throughout the duration of the study. The primary clinical question of interest is: What is the long term effect on safety of OAV101 for patients with SMA who were treated with OAV101 by IV or IT administration?
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participated in an OAV101 clinical trial.
- Written informed consent must be obtained before any assessment is performed.
- Patient/Parent/legal guardian willing and able to comply with study procedures.
You likely can't join if
- There are no specific exclusion criteria for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- South Africa
- China
- Japan
- Canada
- Malaysia
- Saudi Arabia
- Vietnam
- India
- Australia
- Brazil
- Singapore
- United Kingdom
- Taiwan
- United States
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; South Africa; China; Japan; Canada; Malaysia and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.