Rifaximin in the prevention of alcoholic liver disease

Phase 1

• Conditions: iver fibrosis; MedDRA version: 20.0Level: LLTClassification code 10016648Term: Fibrosis liverSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-001856-51-DK
• Lead Sponsor: Aleksander Krag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-10
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1. Liver fibrosis estimated by an Ishak score from 1-4

2. Women of child-bearing potential should use safe anti-conception and provide a negative pregnancy test.

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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1. Known allergy to rifaximin
2. The investigator judge that the patient would not be compliant with trial medicine
3. Antibiotic treatment the prior 4 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified