2022-502911-12-00招募中2 期
A Phase 1/2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
Moderna Therapeutics Inc.2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2026年2月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Incidence and severity of AEs (including mRNA-3927 -related and not related AEs), SAEs, and AEs leading to treatment discontinuation.
研究概览
简要总结
Evaluate the long-term safety of mRNA-3927 administered to participants with PA who have previously participated in Study mRNA-3927-P101
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participated in Study mRNA-3927-P
- •Completed the EOT/ ET Visit in Study mRNA-3927-P101 and enroll in this study such that the first dose in this study is planned to be within 14±3 days of the last dose of mRNA-3927 in mRNA-3927-P101 study.
- •Participant and/or legally authorized representative is willing and able to provide informed consent and/or assent as mandated by local regulations.
- •Participant’s caregiver (and, if able to provide consent/assent, the participant) is willing and able to comply with study-related assessments.
排除标准
- •Not expected to receive clinical benefit from continued mRNA-3927 administration, in the opinion of the Investigator.
- •Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.
- •History of liver and/or kidney transplant.
- •Pregnant or breastfeeding.
- •Sexually active and does not agree to use a highly effective method of contraception during the Treatment Period and for 3 months after the last dose of the mRNA-3927.
结局指标
主要结局
Incidence and severity of AEs (including mRNA-3927 -related and not related AEs), SAEs, and AEs leading to treatment discontinuation.
Incidence and severity of AEs (including mRNA-3927 -related and not related AEs), SAEs, and AEs leading to treatment discontinuation.
次要结局
- Annualized frequency of Investigator-reported MDEs.
- Annualized frequency of Investigator-reported MDE-related hospitalizations.
- Annualized frequency of Investigator-reported PA-related hospitalizations.
- Annualized frequency of Investigator-reported PA-related urgent healthcare encounters.
研究者
Moderna Clinical Trials
Scientific
Moderna Therapeutics Inc.
研究点 (2)
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