Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis

Phase

N/A

Condition

Scar Tissue

Hepatic Fibrosis

Hyponatremia

Treatment

Conventional dose of Rifaximin

Low-dose of Rifaximin

Clinical Study ID

NCT05863364

DFYY2022096

Ages 18-80
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

With a clinical diagnosis of decompensated liver cirrhosis on the basis of typicalclinical manifestations, laboratory tests, imaging appearances and/or representativepathology results of liver biopsy. Decompensation of the disease was defined by atleast having an episode of severe complications, including ascites, SBP, EGVB and HE.

Exclusion

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 screeningvisit
Hepatitis B virus (HBV) DNA ≥ 500 copy/mL，or receipt of standard antiviral treatmentfor hepatitis B for less than 12 months
Receiving antiviral treatment for hepatitis C or receipt of antiviral treatment forhepatitis 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 abuseafter 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 andrespiratory 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

Study Design

Conventional dose of Rifaximin

August 18, 2023

December 31, 2025

Study Description

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.

Connect with a study center

Shanghai East Hospital
Shanghai, 200120
China
Active - Recruiting

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