A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Survival at 28 Days
研究概览
简要总结
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.
详细描述
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.
This study never moved forward due to funding issues.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient with acute alcoholic hepatitis
- •Model for End-Stage Liver Disease (MELD) of 15 or greater
- •Recent alcohol abuse
排除标准
- •Recent infection
- •Other life threatening disease
- •Severe coagulopathy
- •Another non-alcoholic cause of liver disease
研究组 & 干预措施
Pentoxifylline/Placebo
All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days (20-40 treated, 1-20 placebo) with monthly follow up for 90 days.
干预措施: pentoxifylline (Drug)
结局指标
主要结局
Survival at 28 Days
时间窗: 28 days
次要结局
未报告次要终点