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

Launched by XIN ZENG · May 16, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called rifaximin can help prevent the worsening of liver cirrhosis and its complications in patients who have a more severe form of the disease, known as decompensated liver cirrhosis. The study will enroll 150 participants, who will be randomly assigned to three different groups: one group will receive no rifaximin (the control group), another will take a lower dose (600 mg per day), and the last group will take a higher dose (1200 mg per day) for 24 weeks. The researchers will compare the health outcomes of these groups to see if rifaximin makes a difference in preventing complications, improving liver function, and enhancing overall survival.

To be eligible for the trial, participants must have a confirmed diagnosis of decompensated liver cirrhosis and have experienced serious complications related to this condition. However, those with certain recent health issues, severe infections, or specific liver diseases will not be included. Throughout the study, participants can expect to continue their usual treatments, and they will be monitored for any side effects from the medication. This trial aims to provide valuable insights into whether rifaximin can be an effective option for managing liver cirrhosis and improving the health of patients facing this challenging condition.

Gender

ALL

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