The Efficacy and Safety of Rifaximin Treatment

Launched by SUN YAT-SEN UNIVERSITY · Mar 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a drug called Rifaximin in treating patients with liver failure linked to hepatitis B. Specifically, it focuses on those who have mild to moderate symptoms of hepatic encephalopathy, which is a condition that affects brain function due to liver problems. The trial will enroll 124 patients who meet certain criteria, such as being diagnosed with chronic hepatitis B and having specific symptoms related to liver failure. Participants will be randomly assigned to one of two groups: one will receive Rifaximin along with standard liver treatment for four weeks, while the other group will only receive the standard treatment.

Eligible participants are those aged 18 or older who have a confirmed diagnosis of hepatitis B for at least six months and show signs of liver failure with related symptoms affecting their mental function. Throughout the study, patients can expect to be monitored closely for four weeks after starting treatment, with follow-ups continuing for an additional eight weeks to assess their recovery. It’s important to note that certain individuals, including those with severe liver failure or other serious health conditions, may not qualify for this trial. This study aims to find new ways to help improve brain function and overall health in patients dealing with liver issues.

Gender

ALL

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.