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The Efficacy and Safety of Rifaximin Treatment

NCT05786859 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-03-28

No results posted yet for this study

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

Interventions

DRUG

Rifaximin 200 mg

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.

OTHER

Standard Treatment without Rifaximin

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2025-07-31
Completion
2025-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786859 on ClinicalTrials.gov