Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis (RPPCLC)
Decompensated Cirrhosis
About this trial
This is an interventional prevention trial for Decompensated Cirrhosis
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Shanghai East HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
control group
the low-dose rifaximin treatment group
the conventional dose rifaximin treatment group
Group A: Patients in the control group were administered only conventional therapy
Group B
Group C