Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02116556
Eligibility Criteria:
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 Discriminant Function \> 32 points.
Exclusion Criteria:
* Hypersensitivity to Rifaximin
* Advanced Chronic or Terminal illness. Advanced Chronic illness will be defined as: all conditions 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 disabling neurological disease, disabling or uncontrolled oncological conditions, etc ...).
Terminal illness will be defined as any clinical conditions with a survival expectancy less than 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-HIV positive).
* 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 after inclusion.
Because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation 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 sinusoidal fibrosis.
* Hepatocellular carcinoma beyond Milan's criteria diagnosed during the first 7 days after inclusion.
* Complete portal vein thrombosis diagnosed during the first 7 days after inclusion.
* Protocol violation.
* Severe adverse event directly related with Rifaximin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02116556
Study Brief:
Protocol Section:
NCT02116556