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Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
EU CTIS ID: 2024-512584-31-00
What this study is testing
To evaluate the long term safety of AAVAnc80-hOTOF, including late-occurring adverse events.
- Phase II and Phase III (Integrated)
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
- Individuals with OTOF-mediated hearing loss who received an intracochlear administration of AAVAnc80- hOTOF in the AK-OTOF-101 clinical trial (either Part A or Part B).
- Legally authorized representative and/or participant willingness to comply with all study requirements, as evidenced by successful completion of the informed consent process or permission and participant assent process (where appropriate).
You likely can't join if
- Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study. Potential participants will not be excluded based on their sex, gender, race, or ethnicity.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Taiwan
- United States
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Taiwan; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
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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.