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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Liang Bing Lin, MD
lamikin@126.com
13924129928
Backup
Ying Z Lei
leiziy@mail.sysu.edu.cn
13560440923
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 124
Treatments
Experimental: Rifaximin Treatment Group
Sham_comparator: Standard Treatment Group (control group)
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov