Rifaximin (an antibiotic) treatment of acute alcoholic liver injury.

Rifaximin in alcoholic hepatitis: effects on inflammatory and metabolic markers.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002264-33-DK

Enrollment

Registered

2014-07-03

Start date

2014-08-25

Completion date

Unknown

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic hepatitis. MedDRA version: 17.1 Level: LLT Classification code 10001624 Term: Alcoholic hepatitis System Organ Class: 100000004871

Interventions

Trade Name: Xifaxan, Active Substance: 80621-81-4/RIFAXIMIN/based on MPD record: SUB10312MIG Product Name: Rifaximin Product Code: A07AA11 Pharmaceutical Form: Tablet INN or Proposed INN: RIFAXIMIN CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Alcohol intake > 30 g daily for more than 3 months or > 100 g daily for more than 4 weeks. Increased plasma-bilirubin level (>80 mikromol/l) No mechanical bile duct obstruction. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Pregnancy Age < 18 years Treatment with rifaximin within the last 4 weeks Malignancy Allergi towards rifaximin Bowel obstruction

Design outcomes

Primary

Measure	Time frame
Main Objective: Rifaximin treatment reduces various complications to liver disease. In this trial we wish to investigate the potentiel metabolic and inflammatory changes in the blood of patients with alcoholic hepatitis receiving rifaximin therapy.;Secondary Objective: Not applicable;Primary end point(s): Change of the levels in blood of: endotoxin measured as LPS, IL1,2,6,8 and 10, TNF-alpha, CD163, procalcitonine, glutamine, leucine, isoleucine, valine, phenylanine, tyrosine, tryptophane, arteriel ammonia during rifaximin treatment.;Timepoint(s) of evaluation of this end point: Days 0,7,14,21,28 and 90.	—

Measure

Time frame

Main Objective: Rifaximin treatment reduces various complications to liver disease. In this trial we wish to investigate the potentiel metabolic and inflammatory changes in the blood of patients with alcoholic hepatitis receiving rifaximin therapy.;Secondary Objective: Not applicable;Primary end point(s): Change of the levels in blood of: endotoxin measured as LPS, IL1,2,6,8 and 10, TNF-alpha, CD163, procalcitonine, glutamine, leucine, isoleucine, valine, phenylanine, tyrosine, tryptophane, arteriel ammonia during rifaximin treatment.;Timepoint(s) of evaluation of this end point: Days 0,7,14,21,28 and 90.

—

Secondary

Measure	Time frame
Secondary end point(s): Porto-systemic pressure gradient, galactose elimination capacity test, kidney function (creatinine, carbamide, creatinine clearance), continuous reaction test, number connection test;Timepoint(s) of evaluation of this end point: Initially and after 90 days.	—

Countries

Denmark

Contacts

Public ContactHenriette Ytting

Henriette Ytting

henriette.ytting@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026