Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- serum HBsAg level
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B.
详细描述
This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B. Patients with chronic hepatitis B who met eligibility criteria were randomly assigned (1:1) to receive either metformin (1000 mg, oral, once a day) or placebo (oral, once a day) for 24 weeks in addition to their ongoing entecavir therapy. Patients and investigators were both blinded to group allocation. The primary outcome, serum HBsAg level (log IU/mL) at weeks 24 and 36, was analysed using a linear mixed-effect model. The intention-to-treat populations were included in primary and safety analyses.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBeAg-negative chronic hepatitis B
- •Ongoing treatment with Entecavir for more than 12 months
- •HBV DNA < 500 IU/mL
- •Quantitative HBsAg < 3 log IU/mL
- •ALT and AST < 2 × upper limit of normal (ULN)
- •Agree to take contraceptive measures during participation for women of a fertile age
- •Agree not to engage in other clinical trials during participation
- •Understand and sign the informed consent form before taking any steps related to this study
排除标准
- •Diabetes mellitus
- •Alcoholic liver disease
- •Drug-induced liver damage
- •Autoimmune liver disease
- •Decompensated cirrhosis
- •Liver cancer
- •Liver transplantation
- •Pregnant or lactating women
- •Other conditions unsuitable for participation
研究组 & 干预措施
Combination Therapy
Metformin as add-on to entecavir therapy in patients with chronic hepatitis B
干预措施: Metformin & Entecavir (Drug)
Standard Therapy
Entecavir monotherapy in patients with chronic hepatitis B
干预措施: Placebo & Entecavir (Drug)
结局指标
主要结局
serum HBsAg level
时间窗: weeks 24 and 36 after adding metformin or a placebo
log IU/mL
次要结局
- triglycerides(weeks 24 and 36 after adding metformin or a placebo)
- weight(weeks 24 and 36 after adding metformin or a placebo)
- body mass index(weeks 24 and 36 after adding metformin or a placebo)
- fasting glucose(weeks 24 and 36 after adding metformin or a placebo)
- HbA1c(weeks 24 and 36 after adding metformin or a placebo)
- total cholesterol(weeks 24 and 36 after adding metformin or a placebo)
研究者
Fu-Sheng Wang
Study Chair
Beijing 302 Hospital