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

Phase 1

Conditions: Alcoholic hepatitis.
MedDRA version: 17.1Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2014-002264-33-DK

Lead Sponsor: Ole Hamberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: <br>endotoxin measured as LPS, IL1,2,6,8 and 10, TNF-alpha, CD163, procalcitonine, glutamine, leucine, isoleucine, valine, phenylanine, tyrosine, tryptophane, arteriel ammonia<br>during rifaximin treatment.;Timepoint(s) of evaluation of this end point: Days 0,7,14,21,28 and 90.

Secondary Outcome Measures

Name	Time	Method
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.