Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis: a Multi-center Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The proportion of patients with progression of liver cirrhosis
研究概览
简要总结
It is still not clear whether rifaximin can prevent the progression of liver cirrhosis, reduce the overall complications and improve the survival in patients with decompensated cirrhosis. This is a multi-center open-labelled randomized prospective study to evaluate the efficacy and safety of rifaximin in preventing the progression and complications in cirrhotic patients, and explore its reasonable dosage and possible mechanism. A total of 150 patients with decompensated liver cirrhosis will be enrolled in the study and randomly divided into three groups (the control group (A), the low-dose rifaximin treatment group (B), and conventional dose rifaximin treatment group (C)) with a ratio of 1:2:2. The patients in group B are given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks, and the patients in group C are delivered 1200mg/d (600mg, bid) of rifaximin .During the entire study period, all other therapeutic strategies are kept unchanged in all the groups as long as possible. The proportion of patients with progression of cirrhosis, the incidence of total complications and each complication, survival rate and time, liver function and adverse events will be compared among the three groups. This study might provide a new feasible method with clinical application prospects for preventing the progression and reducing the incidence of liver cirrhosis related complications, improve the prognosis of patients with decompensated liver cirrhosis, and save medical resources.
详细描述
Rifaximin has been recommended as a prophylactic drug for hepatic encephalopathy (HE) and spontaneous bacterial peritonitis (SBP), the two major complications of liver cirrhosis. However, it is still not clear whether rifaximin can prevent the progression of liver cirrhosis, reduce the overall complications and improve the survival in patients with decompensated cirrhosis. Additionally, the role of rifaximin in the treatment of liver cirrhosis has not been fully clarified. We designed a multi-center open-labelled randomized prospective study to evaluate the efficacy and safety of rifaximin in preventing the progression and complications in cirrhotic patients, and explore its reasonable dosage and possible mechanism. A total of 150 patients with decompensated liver cirrhosis will be enrolled in the study. They will be randomly divided into three groups (the control group (A), the low-dose rifaximin treatment group (B), and conventional dose rifaximin treatment group (C)) with a ratio of 1:2:2. The patients in group B are given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks, and the patients in group C are delivered 1200mg/d (600mg, bid) of rifaximin .During the entire study period, all other therapeutic strategies, such as antiviral agents, non-selective beta-blockers, liver protectants, and diuretics, are kept unchanged in all the groups as long as possible. The proportion of patients with progression of cirrhosis, acute decompensation, acute-on-chronic liver failure (ACLF), decompensation and stable decompensated cirrhosis, the incidence of total complications and each complication, survival rate and time, liver function and adverse events will be compared among the three groups. This study might provide a new feasible method with clinical application prospects for preventing the progression and reducing the incidence of liver cirrhosis related complications, improve the prognosis of patients with decompensated liver cirrhosis, and save medical resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a clinical diagnosis of decompensated liver cirrhosis on the basis of typical clinical manifestations, laboratory tests, imaging appearances and/or representative pathology results of liver biopsy. Decompensation of the disease was defined by at least having an episode of severe complications, including ascites, SBP, EGVB and HE.
排除标准
- •Episodes of overt HE, EGVB or SBP within 4 weeks before the screening visit
- •Uncontrolled severe infection or antibiotic use within 2 weeks before the screening visit
- •Hepatitis B virus (HBV) DNA ≥ 500 copy/mL，or receipt of standard antiviral treatment for hepatitis B for less than 12 months
- •Receiving antiviral treatment for hepatitis C or receipt of antiviral treatment for hepatitis C within 12 months before the screening visit
- •If patients with autoimmune liver disease have been treated with ursodeoxycholic acid, hormone or other immunosuppressants, the dose stability time is less than 6 months
- •With history of alcoholism in the last 12 weeks or unwilling to stop alcohol abuse after inclusion (≥ 20 g/day for women or ≥ 30 g/day for men)
- •With confirmed or suspected malignancies
- •Severe jaundice (serum total bilirubin level ≥ 85 μmol/L)
- •Obvious renal dysfunction (serum creatinine ≥ 1.2-fold of upper normal limits)
- •Severe electrolyte abnormality (serum sodium level < 125 mmol/L )
- •Life-threatening leucocytopenia (white blood cell count < 1 × 10^9/L )
- •Poorly controlled hypertension, diabetes mellitus or other severe heart and respiratory diseases (NYHA Ⅲ/Ⅳ, COPD GOLD C)
- •With drug abuse, methadone treatment, drug dependence or mental illness
- •HIV seropositivity
- •Known to be allergic to rifaximin
- •Pregnant and lactating women or women who do not rule out pregnancy
- •Those who have participated in other drug trials within 12 weeks
研究组 & 干预措施
the low-dose rifaximin treatment group
Group B
干预措施: Low-dose of Rifaximin (Drug)
the conventional dose rifaximin treatment group
Group C
干预措施: Conventional dose of Rifaximin (Drug)
结局指标
主要结局
The proportion of patients with progression of liver cirrhosis
时间窗: 24 weeks
The proportion of patients with progression of liver cirrhosis, which is defined as at least one additional stage of liver cirrhosis staging during the 24-week treatment phase
次要结局
- Liver transplantation free survival time(24 weeks)
- Complication-free survival time(24 weeks)
- The proportion of patients with stable decompensated cirrhosis(24 weeks)
- All-cause mortality(24 weeks)
- Incidence of overall complications resulting from decompensated liver cirrhosis(12 and 24weeks)
- The proportion of patients with recompensation of cirrhosis(24 weeks)
- Child-Pugh score(24 weeks)
- Model for end-stage liver disease (MELD) score(24 weeks)
- Incidence of various complications of liver cirrhosis, including: refractory ascites, SBP, EGVB, OHE, AKI/HRS, PHC, etc.(12 weeks and 24 weeks)
- The proportion of patients with acute decompensated (AD)(12 and 24 weeks)
- The proportion of patients with different Child-Pugh class(24 weeks)
- The proportion of patients with progression of liver cirrhosis(12 weeks)
研究者
Xin Zeng
Director of the department of gastroenterology
Shanghai East Hospital