Clinical trialObservationalEnrolling by invitation
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products
- Outcome
- Ongoing
- Phase
- Observational
- Status
- Enrolling by invitation
- Study type
- Observational
- Start
- 31 July 2025
- Expected end
- 31 March 2040
- Enrollment
- 400 participants
- Sites
- 3
- Primary outcomes
- Long-term safety of previous A2 Bio GT treatment
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 20 May 2026
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Brief summary public domain (ClinicalTrials.gov)
This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.
Detailed description public domain (ClinicalTrials.gov)
This is a long-term follow-up study designed to evaluate delayed safety events and long-term efficacy of A2 Bio GT products for participants who received any amount of A2 Bio GT products in a previous interventional study. No further interventional treatment is administered in this study. Participants will enroll in this long-term follow-up study upon completion of 2 years of follow-up in the assigned interventional study in which they received treatment. Participants will be followed for up to 15 years after administration of A2 Bio GT product. This study will collect long-term safety and efficacy data as outlined by the FDA guidance for long-term follow-up for GT products.