The Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection Followed by Diammonium Glycyrrhizinate Enteric-coated Capsules and Combined With Entecavir on the Treatment of Chronic Hepatitis B
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 480
- 主要终点
- Change of ALT(Alanine aminotransferase)
研究概览
简要总结
This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.
详细描述
Chronic hepatitis B(HBV) has a high prevalence (>8%) in China. Entecavir, aguanosine analog, is a potent and selective inhibitor of HBV DNA polymerase.
Glycyrrhizin has been used for more than 30 years in the treatment of liver diseases in Asian countries, who can relieve necro-inflammatory and liver fibrosis or cirrhosis Recent study has shown that inflammation plays the important role in chronic HBV and fibrosis or cirrhosis disease progression, but antiviral therapy only may not reduce inflammation ideally. The addition of glycyrrhizin to entecavir in the treatment may slow disease progression in patients with chronic HBV and advanced fibrosis or cirrhosis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatitis B surface antigen [HBsAg]-positive,
- •Either hepatitis B e antigen (HBeAg)-positive or HBeAgnegative/hepatitis B e antibody (HBeAb)-positive disease were eligible,
- •Serum alanine aminotransferase (ALT) levels 3-10×the upper limit of normal (ULN),serum total bilirubin(TBIL)levels<2×ULN
排除标准
- •Co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency virus;
- •Other forms of liver disease;
- •More than 24 weeks of therapy with a nucleoside or nucleotide analog with activity against HBV, and therapy with any anti-HBV drug within 24 weeks prior to randomization;
- •More than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin;
- •Has decompensated liver function or has a hint of hepatocellular carcinoma (HCC);
- •During the study patients were not allowed to use other medicines.
研究组 & 干预措施
Control group
Entecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo
干预措施: Entecavir (Drug)
Control group
Entecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo
干预措施: Magnesium Isoglycyrrhizinate Placebo (Drug)
Control group
Entecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo
干预措施: Diammonium Glycyrrhizinate Placebo (Drug)
Experimental group
Entecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate
干预措施: Entecavir (Drug)
Experimental group
Entecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate
干预措施: Magnesium Isoglycyrrhizinate (Drug)
Experimental group
Entecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate
干预措施: Diammonium Glycyrrhizinate (Drug)
结局指标
主要结局
Change of ALT(Alanine aminotransferase)
时间窗: baseline and 24 weeks
The ALT levels of plasma are measured at baseline and at 24 weeks. The normal value was 0-40 U/L.
次要结局
- Change of Liver inflammatory(baseline and 24 weeks)
- Change of Liver Fibrosis(baseline and 96 weeks)