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临床试验/NCT00137059
NCT00137059已完成不适用

Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers

Dr. Marco L.A. Sivilotti2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2002年11月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
serum a-GST relative to baseline

研究概览

简要总结

It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will undergo baseline tests to ensure that they do not have liver damage at the time of enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of acetaminophen or a placebo three times a day for four days. Subjects will have blood work drawn on a daily basis to monitor the status of the liver. These tests will include conventional markers of liver injury in addition to a novel biomarker of liver function, a-GST. Previous work in the investigators' group has shown that a-GST is a more sensitive indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x 2). However, it has never been used to study the alcoholic population. The investigators believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who self-report consuming at least 6 drinks per day, daily, for at least 6 weeks and who are currently enrolled at the Detoxification Center, Hotel Dieu Hospital.
  • Last alcohol consumption occurring between 12 and 72 hours prior to screening for study.

排除标准

  • Individuals with a self-reported or previously documented history of hepatitis A, B, C or HIV.
  • Individuals who have ingested any acetaminophen regardless of dose in the previous 48 hours.
  • Individuals who have ingested > 4 grams of acetaminophen/day in any of the previous 7 days.
  • Individuals < 18 years of age.
  • Individuals with abnormal liver function at baseline (defined as AST or ALT > 120 IU/L, International Normalized Ratio [INR] > 1.5, and a-GST > 7.5 7 :g/L).
  • Individuals who have an allergy or sensitivity to acetaminophen.

结局指标

主要结局

serum a-GST relative to baseline

次要结局

  • conventional liver function tests (LFTs)

研究者

发起方
Dr. Marco L.A. Sivilotti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Marco L.A. Sivilotti

Professor of Emergency Medicine, and of Biomedical & Molecular Science

Queen's University

研究点 (2)

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