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:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT02075918
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 ≥ and ≤ 70 years of age.
* Active alcohol abuse within the past 3 months.
* Has an Aspartate Aminotransferase (AST) \> Alanine Aminotransferase (ALT).
* Elevated Total Bilirubin level \> 3.0.
* Absence of autoimmune liver disease (ANA\>1/320).
* Absence of hepatitis B infection.
* A liver biopsy, and/or a clinical picture consistent with alcoholic hepatitis.
* The "Start Date" (is the date of the liver biopsy or ≤ to 1 week \[72 hours is preferred\] from the time of admission).
Exclusion Criteria:
* Hepatocellular carcinoma.
* Complete portal vein thrombosis.
* Advanced or terminal extrahepatic diseases.
* Lack of consent to participate in the study.
* Pregnancy.
* Received more than 3 days of treatment with (prednisolone or pentoxifyllin) prior to start date.
Control patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02075918
Study Brief:
Protocol Section:
NCT02075918