跳至主要内容
临床试验/NCT07424157
NCT07424157招募中不适用

Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products

Seattle Children's Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年6月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Incidence of delayed adverse events

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Enrolled in an SCTx GTP clinical trial;
  • Received or planned to receive an SCTx GTP;
  • Subject and/or legally authorized representative have provided consent/assent for study participation.

排除标准

  • 未提供

结局指标

主要结局

Incidence of delayed adverse events

时间窗: 15 years post-final infusion of SCTx GTP

The type, frequency, severity, and duration of adverse events considered related to the SCTx gene therapy product (GTP) the participant received.

Long-term persistence of SCTx Gene Therapy Products

时间窗: 15 years post-final infusion

Monitor for long-term persistence of SCTx GTPs.

Long-term clinical outcomes following treatment with SCTx GTP

时间窗: 15 years post-final infusion

Death from any cause and first relapse following an initial remission

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Colleen Annesley

SCTx Medical Director

Seattle Children's Hospital

研究点 (1)

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