NCT06832410招募中3 期
A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 7
- 主要终点
- Proportion of Participants who are Insulin Independent
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence
- •Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks
- •Consistent use of continuous glucose monitor (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study
排除标准
- •Prior islet cell transplant, organ transplant (other than kidney transplant), or cell therapy, except prior pancreatic graft that failed within the first 4 weeks
- •Participants had >1 kidney transplant procedure
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
VX-880
Experimental
干预措施: Biological/Vaccine (Biological)
结局指标
主要结局
Proportion of Participants who are Insulin Independent
时间窗: At 1 year After VX-880 infusion
次要结局
- Proportion of participants who achieve insulin independence and are insulin independent 12 months later(1 year after achieving insulin independence)
- Change from Baseline in glycosylated hemoglobin (HbA1c)(Baseline, At 1 year After VX-880 infusion)
- Proportion of Participants who Maintain Insulin Independence for at least 1 year(From VX-880 infusion to End of Study (up to 2 years))
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Signing of informed consent to End of Study (up to 2 years))
研究者
研究点 (7)
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