JPRN-jRCT1031220022招募中未知
Therapeutic effect of nalmefene on alcohol-related liver disease: multicenter clinical trial (pilot study)
Ikejima Kenichi0 个研究点目标入组 15 人开始时间: 2022年4月14日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1) Outpatients aged 20 to 80
- •2) Patients who have a heavy drinking habit exceeding 60 g / day for men and 40 g / day for women in terms of pure alcohol and meet the diagnostic criteria of the ICD-10 diagnostic guidelines for alcohol dependence syndrome
- •3) Patients who did not abstain from alcohol after the pre-observation period (4 to 12 weeks) and had a serum GGT level of 100 IU / L or higher
- •4) Patients who have written consent to participate in this study
排除标准
- •1) Patients treated for viral hepatitis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis or metabolic liver disease)
- •2) Patients with decompensated cirrhosis (Child-Pugh grade C)
- •3) Patients who are taking contraindications of nalmefene such as opioids
- •4) Patients with advanced or malignant tumor requiring treatment
- •5) Pregnant or suspected pregnant, lactating patients
- •6) Patients judged to be ineligible by a doctor
研究者
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