Rifaximin treatment for patients with hepatitis B related liver failure

The Efficacy and Safety of Rifaximin In The Treatment of HBV Associated Acute-on-Chronic Liver Failure Patients With Mild to Moderate Hepatic Encephalopathy

This study is testing if the antibiotic Rifaximin can help improve brain function in patients with liver failure caused by hepatitis B.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05786859 on ClinicalTrials.gov

What this trial studies

This clinical trial involves 124 patients diagnosed with hepatitis B associated acute on chronic liver failure and mild to moderate hepatic encephalopathy. Participants will be randomly assigned to either a Rifaximin treatment group, receiving 400 mg of Rifaximin three times daily for four weeks, or a control group receiving standard treatment for liver failure. The primary outcome is the reversal of hepatic encephalopathy symptoms within four weeks, with follow-up extending to 12 weeks post-treatment. The study aims to evaluate the efficacy and safety of Rifaximin in this patient population.

Who should consider this trial

Good fit: Ideal candidates are HBsAg positive patients with chronic hepatitis B experiencing acute on chronic liver failure and mild to moderate hepatic encephalopathy.

Not a fit: Patients with active infections or severe complications such as hepatorenal syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from hepatic encephalopathy due to liver failure.

How similar studies have performed: Previous studies have indicated potential benefits of Rifaximin in similar conditions, suggesting this approach may be promising.

Eligibility criteria

1. Inclusion Criteria:

   * The confirmed HBsAg positive patients with chronic hepatitis B are defined as HBsAg positive for at least 6 months or evidence of chronic HBV infection;
   * Acute onset, progressive deepening of jaundice, serum total bilirubin (TB) ≥ 85umol/L and severe coagulation dysfunction, international standardized ratio (INR) ≥ 1.5 or plasma prothrombin activity (PTA)\<40%
   * The score of the psychological test scale of hepatic encephalopathy is less than - 4 points or mild to moderate (degree I or II) manifestations of hepatic encephalopathy, including the decline of computational ability, timing and orientation, personality change, lethargy, and positive flapping wing tremor.
   * Be able and willing to provide informed consent and comply with the test requirements.
2. Exclusion Criteria:

   * There are definite infections or hepatorenal syndromes during screening;
   * Upper gastrointestinal bleeding occurred within 1 week before screening;
   * Have used sedative drugs such as "benzodiazepines" or other psychotropic drugs within one week before screening;
   * Those with severe primary heart, lung, kidney and other important organ dysfunction affecting life expectancy;
   * HIV infection;
   * Uncontrolled malignant tumor, nerve and mental abnormality;
   * Patients who are allergic to the study drugs and excipients;
   * Pregnant or lactating women;
   * In the late stage of liver failure, MELD score\>35;
   * Other circumstances in which the researcher believes that the patient should not participate in this study.

Where this trial is running

Guangzhou, Guangdong

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Liang Bing Lin, MD

Conditions Liver Failure, Acute on Chronic; Hepatic Encephalopathy; HBV; Hepatitis B; Rifaximin; Effect of Drug