Letrozole in Patients With Hepatopulmonary Syndrome: A Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Alveolar-Arterial Oxygen
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and possible benefit of letrozole compared to placebo in patients with Hepatopulmonary Syndrome.
详细描述
This study is a phase II randomized, double-blind, placebo-controlled parallel trial of 20 subjects with hepatopulmonary syndrome designed to assess the effect of letrozole 2.5 mg orally daily or placebo for 6 months on the alveolar-arterial oxygen gradient (AaPO2).
Subjects at each site will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin letrozole with follow-up clinic visits and testing at 3 months, and 6 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Letrozole Group
Subjects with hepatopulmonary syndrome will get the study drug letrozole
干预措施: Letrozole (Drug)
Placebo Group
Subjects with hepatopulmonary syndrome will get the study placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Alveolar-Arterial Oxygen
时间窗: 6 months
To determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with HPS.
次要结局
- Hormone Levels(6 months)
- Oxygen Saturation(3 and 6 months)
- Side Effects(6 months)
研究者
Hilary M. DuBrock, MD
Principal Investigator
Mayo Clinic