Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis

Completed

Conditions studied: Alcoholic Hepatitis, Control Patients

In brief

Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity of disease and survival.

Key facts

Study ID

NCT02075918

Run by

University of Pittsburgh

People needed

376

Starts

2014-05-01

Expected to finish

2019-05-31

Last updated by the study team

2019-06-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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