NCT07554508尚未招募不适用
A Prospective Registry for Belzutifan in the Treatment of Von Hippel-Lindau (VHL) Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study aims to evaluate the Belzutifan's efficacy, drug safety, disease course, and the health-economic impact of the treatment to Von Hippel-Lindau (VHL) syndrome.
详细描述
Adult patients diagnosed with VHL syndrome who choose to use belzutifan for their treatment will be identified and invited to participate in this registry. Clinical data, laboratory tests, imaging results and QOLs will be collected from subjects at baseline, every 3 months for the first year, then every 6 months until month 36 or cessation of the medication, whichever occurs first.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult patients (age 18 or above) with confirmed VHL-spectrum disease through clinical and/or genetic diagnosis.
- •The patient decided to use Belzutifan for their treatment.
排除标准
- •Tumour requiring immediate resection.
- •Pregnancy or unwillingness to use contraception if of childbearing potential.
- •Uncontrolled comorbidities (e.g., active infection, severe cardiopulmonary disease).
研究组 & 干预措施
Belzutifan Group
Subjects received Belzutifan
结局指标
主要结局
Objective response rate
时间窗: Month 6 and Month 12
RECIST 1.1
次要结局
- Radiographic response(Month 6 and Month 12, Month 18, Month 24, Month 30 and Month 36)
- Health-economic impact of belzutifan(Month 6, Month 12, Month,18, Month 24, Month 30, Month 36)
- Change in Quality of Life score(Baseline, Month 6 and Month 12)
研究者
NG Chi Fai
Professor
Chinese University of Hong Kong
研究点 (1)
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