NCT06544798Enrolling By Invitation2 期
Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
适应症
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 276
- 试验地点
- 16
- 主要终点
- Number of participants with study drug-related adverse events and serious adverse events
研究概览
简要总结
This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
详细描述
Individual participation in this study will last approximately 48 months for participants who received AAV2-hAQP1 in Study MGT-AQP1-201 and at least 60 months for participants who receive AAV2-hAQP1 in Study MGT-AQP1-202.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received study drug in Study MGT-AQP1-201
排除标准
- •Withdrew consent to participate in Study MGT-AQP1-201.
结局指标
主要结局
Number of participants with study drug-related adverse events and serious adverse events
时间窗: From study start until Month 60 post-treatment
次要结局
未报告次要终点
研究者
研究点 (16)
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