The Efficacy and Safety of Rifaximin Treatment

NCT05786859 | Unknown Early Phase 1

• 1 other identifier: Efficacy of Rifaximin
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The reversal rate of hepatic encephalopathy between 2 groups in 4 weeks.

  The reversal rate of hepatic encephalopathy in the 2 groups within 4 weeks will be recorded.

  4 weeks

Secondary Outcomes (2)

• The incidence of complications related to liver failure within 12 weeks between 2 groups.

  12 weeks

• The survival rate between 2 groups within 12 weeks.

  12 weeks

Study Arms (2)

Rifaximin Treatment Group

EXPERIMENTAL

Drug: Rifaximin 200 mg

Standard Treatment Group (control group)

SHAM COMPARATOR

Other: Standard Treatment without Rifaximin

Interventions

Rifaximin 200 mg DRUG

Rifaximin Treatment Group:on the basis of comprehensive treatment of liver failure, Rifaximin will be added, three times a day, 400mg each time, for a total of 4 weeks, and we will observe until 12 weeks after withdrawal.

Rifaximin Treatment Group

Standard Treatment without Rifaximin OTHER

The standard treatment group (control group), which will receive routine comprehensive treatment for liver failure without Rifaximin.

Standard Treatment Group (control group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (17)

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Related Links

• Related Info

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Hepatic Encephalopathy; Hepatitis B

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Liang Bing Lin, MD

CONTACT

13924129928; lamikin@126.com

Ying Z Lei

CONTACT

13560440923; leiziy@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Efficacy and Safety of Rifaximin In The Treatment of HBV Associated Acute-on-Chronic Liver Failure Patients With Mild to Moderate Hepatic Encephalopathy.

Model Details: Single center randomized controlled trial.

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 28, 2023
• Study Start: March 9, 2023
• Primary Completion: July 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)