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NCT07424157 · ClinicalTrials.gov registry record
Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products
A clinical trial, sponsored by Seattle Children's Hospital.
- Recruiting
- Registry status
- 500
- Enrollment target
NCT07424157: Recruiting study, sponsored by Seattle Children's Hospital.
NCT07424157 is a clinical trial that is actively recruiting participants, run by Seattle Children's Hospital. The registered enrollment target is 500 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07424157 is actively recruiting participants, sponsored by Seattle Children's Hospital.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
Study Summary
Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.
Primary Outcome
The type, frequency, severity, and duration of adverse events considered related to the SCTx gene therapy product (GTP) the participant received.
Interventions
- OTHER Long term follow up in all patients who received an SCTx gene therapy product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2026-06-15 |
| Est. Completion | 2041-03-31 |
What NCT07424157 shows while recruiting
NCT07424157 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Long term follow up in all patients who received an SCTx gene therapy product is the first listed.
NCT07424157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07424157 about?
NCT07424157 is a clinical study titled "Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products". Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food a...
What is the current status of trial NCT07424157?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2026-06-15. Estimated completion is 2041-03-31.
What interventions are being tested in trial NCT07424157?
The interventions under investigation include: Long term follow up in all patients who received an SCTx gene therapy product (OTHER).
Who is sponsoring clinical trial NCT07424157?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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