Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

Last updated: November 3, 2016
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Trial Status Unknown

Phase

2

Condition

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT02116556
RIFA-AAH.
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥18 and <70 years of age.

  • Active alcohol abuse and excessive alcohol consumption prior to admission defined as > 50 g per day for men and> 40 g per day for women.

  • Jaundice (Bilirubin >2 mg/dl) for no more than 3 months.

  • Clinical suspicion of Alcoholic Hepatitis with a modified Maddrey's DiscriminantFunction > 32 points.

Exclusion

Exclusion Criteria:

  • Hypersensitivity to Rifaximin

  • Advanced Chronic or Terminal illness. Advanced Chronic illness will be defined as: allconditions evolved into a clinical stage to limit the patient's functional status (eg,heart failure NYHA> II, COPD PCO2> 50 mmHg or PO2 <60 mmHg, stroke or other disablingneurological disease, disabling or uncontrolled oncological conditions, etc ...). Terminal illness will be defined as any clinical conditions with a survival expectancy lessthan 3 months

  • Hepatocellular carcinoma (previously diagnosed) beyond Milan's criteria.

  • Complete portal vein thrombosis (previously diagnosed).

  • Autoimmune liver disease.

  • Hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIVpositive).

  • Pregnancy or nursing.

  • Use of Rifaximin during the previous 2 months.

  • Treatment with Pentoxifylline.

  • Lack of informed consent. Removal criteria:

  • Lack of histological confirmation of Alcoholic Hepatitis during the first 7 days afterinclusion. Because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histologicalconfirmation is required in all patients (preferably through a transjugular biopsy):alcoholic hepatitis will be diagnosed on the presence of the following histologic features: Hepatocellular damage (eg, hepatocyte ballooning and presence of Mallory-Denk bodies). Inflammatory infiltrate (predominantly polymorphonuclear cells). Pericellular or sinusoidalfibrosis.

  • Hepatocellular carcinoma beyond Milan's criteria diagnosed during the first 7 daysafter inclusion.

  • Complete portal vein thrombosis diagnosed during the first 7 days after inclusion.

  • Protocol violation.

  • Severe adverse event directly related with Rifaximin.

Study Design

Total Participants: 29
Study Start date:
April 01, 2013
Estimated Completion Date:
December 31, 2016

Study Description

Design: Open multicenter comparative study. A cohort (n = 66) will receive rifaximin (1200 mg / d) for 90 days. Results will be compared with those of a cohort of AAH prospectively included in an observational study. Both groups with a uniform treatment protocol (which includes the administration of corticosteroids and standardized treatment for complications of liver failure). Patients will be monitorized until hospital discharge and a follow-up visit at 7, 30, 45, 60 and 90 days will be performed.

Endpoints:

  1. Primary endpoint: Bacterial infections after 90 days.

  2. Secondary endpoints: :

2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival

Connect with a study center

  • Hospital Universitari Germans Trias i Pujol

    Barcelona,
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona,
    Spain

    Site Not Available

  • Vall d'Hebron Hospital

    Barcelona,
    Spain

    Site Not Available

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