Recompensation in Alcohol Related Hepatitis- a Prospective Cohort with Alcohol Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change from baseline in the proteomic profile
研究概览
简要总结
Genetic activity and metabolic changes may be part of the pathogenesis in alcohol related hepatitis. We do not know exactly how alcohol cessation affects liver functions and metabolism.
The aim of this study is to assess the impact of alcohol cessation in patients with alcohol related hepatitis and gain knowledge of the metabolic and genetic functions of the liver during remission and recompensation from alcohol related hepatitis.
The study will assess
- The effect of alcohol cessation on the liver.
- The biological mechanisms involved in healing after alvohol-cessation
- The effect of motivational enhcament therapy in alcohol cessation after alcohol related hepatitis.
- The metabolic changes of lipids and proteins in the liver Participants are offered motivational enhancement therapy and standard of care.
详细描述
In a prospective incidence cohort study participants will be followed from diagnosis of Alcohol related Hepatitis (AH) until death or withdrawal from the cohort.
Participants will be included consecutively within one month of diagnosis.
All persons diagnosed with AH, and all patients with a debut of AH during admission, regardless of the reason for admission, are eligible for inclusion.
The study does not compromise diagnostics or treatment of AH, cirrhosis or comorbidities.
Inclusion criteria are: clinical suspicion of AH, supported by biochemistry (bilirubin 50 mmol/l or higher) and ultrasound or other imaging techniques; informed written consent.
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
- 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
- •Clinical suspicion of AH, supported by biochemistry (bilirubin 50 mmol/l or higher) and ultrasound or other imaging techniques.
- •Informed written consent.
排除标准
- •People where the diagnosis of AH is questioned with reasonable doubt.
- •Withdrawal of informed consent.
- •Persons eligible for inclusion where the investigational program is delayed or not initiated within two months after the diagnosis of suspected AH.
- •Persons with hepatocellular carcinoma
结局指标
主要结局
Change from baseline in the proteomic profile
时间窗: 12 months
Change from baseline to 12 months in the proteomic profile in the liver tissue
Change from baseline in the lipidomic profile
时间窗: 12 months
Changes from basline to 12 months in the lipidomic profile in the liver tissue
Number of participants in recompensation
时间窗: 12 months
Number of patients who achieve recompensation/remission from AH after 12 months
次要结局
- Change in alcohol use from baseline(12 months)
- Effect of motivational enhancement therapy(3 months)
研究者
Nina Kimer
MD, PhD, Associate Professor
Copenhagen University Hospital, Hvidovre