Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis (RIFA-AAH)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|