The Efficacy and Safety of Rifaximin Treatment

• Status: Recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

Summary

There will be 124 patients diagnosed as hepatitis B associated acute on chronic liver failure with mild to moderate hepatic encephalopathy will be enrolled in this study according to the inclusion and exclusion criteria, and will be randomly divided into two groups as 1:1.First group is called Rifaximin group, on the basis of comprehensive treatment of liver failure, Rifaximin (Alfa Sigma S.p.A) is added, three times a day, 400 mg each time, for a total of 4 weeks, and observed until 12 weeks after withdrawal. The other group is called standard treatment group (control group), which will receive routine comprehensive treatment for liver failure. The reversal of mild to moderate hepatic encephalopathy in the two groups of patients will be observed within 4 weeks, then follow up to 12 weeks.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Rifaximin

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.