A Randomized Controlled Trial of Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- serum ALT
概览
简要总结
The goal of this clinical trial is to learn if drug hydroxychloroquine works to treat steatohepatitis in adults. It will also learn about the safety of drug hydroxychloroquine. The main questions it aims to answer are:
Does drug hydroxychloroquine improve steatohepatitis? What medical problems do participants have when taking drug hydroxychloroquine? Researchers will compare drug hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if drug hydroxychloroquine works to treat steatohepatitis.
Participants will:
Take drug hydroxychloroquine 400mg or hydroxychloroquine 200mg or placebo every day for 12 months Visit the clinic once every 3 months for checkups and tests
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
- Triple (Participant, Care Provider, Investigator)
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
- •Participants must be at least 18 years old.
- •Participants must be able to return for scheduled follow-up visits during specific time points within the 12-month study period.
- •Diagnosis of fatty liver confirmed by abdominal ultrasound or magnetic resonance imaging (MRI).
- •Evidence of hepatic inflammation for more than three months, indicated by alanine aminotransferase (ALT) \> 41 IU/L.
排除标准
- •Participants younger than 18 years old.
- •Pregnant or breastfeeding women.
- •Active viral hepatitis, determined by serum HBV or HCV viral load.
- •Currently taking hydroxychloroquine (HCQ) for other medical conditions or indications.
- •Known history of hypersensitivity or severe adverse drug reaction to HCQ.
- •Presence of retinal maculopathy.
研究组 & 干预措施
HCQ 400mg
干预措施: Hydrochloroquine (Drug)
HCQ 200mg
干预措施: Hydrochloroquine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
serum ALT
时间窗: Every 3 months, for 1 year
次要结局
未报告次要终点