Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis (RIFA-AAH)
|ClinicalTrials.gov Identifier: NCT02116556|
Recruitment Status : Enrolling by invitation
First Posted : April 17, 2014
Last Update Posted : November 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcoholic Hepatitis||Drug: Prednisone Drug: Rifaximin||Phase 2|
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.
- Primary endpoint: Bacterial infections after 90 days.
- Secondary endpoints: :
2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Prednisone
Prednisone PO 40mg/day for 30 days plus standard supportive care measurements
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.
Experimental: Prednisone plus Rifaximin
Prednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements
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
- Rate of bacterial infections [ Time Frame: 90 days ]Development of any bacterial infection.
- Rate of Decompensations of Liver Cirrhosis [ Time Frame: 90 days ]
Development of any liver cirrhosis decompensations
- Hepatic Encephalopathy
- Acute Kidney Injury (including Hepatorenal Syndrome)
- Acute variceal bleeding
- Endotoxemia serum levels [ Time Frame: 90 days ]Measurement of serum changes in endotoxemia levels during the rifaximin treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116556
|Hospital de la Santa Creu i Sant Pau|
|Hospital del Mar|
|Hospital Universitari Germans Trias i Pujol|
|Vall d'Hebron Hospital|
|Principal Investigator:||Victor Vargas, MD||Internal Medicine Service. Vall d'Hebron Hospital|