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Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

NCT02116556 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-11-04

No results posted yet for this study

Summary

Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis.

The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

Prednisone

Prednisone PO 40mg/day or IV equivalent dosage for 30 days. Patients not responding at 7 days (e.g. Lille Model ≥ 0.45) treatment with Prednisone will be suspended.

DRUG

Rifaximin

Rifaximin PO 1200 mg/day for 90 days

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Hospital del Mar

    collaborator OTHER

  • Hospital de Sant Pau

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Victor Vargas, MD · Internal Medicine Service. Vall d'Hebron Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02116556 on ClinicalTrials.gov