InTeam Human Biorepository

InTeam: Integrated approaches for identifying molecular targets in alcoholic hepatitis

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.

Trial Website: https://clinicaltrials.gov/show/NCT02075918

Are you Eligible? (Inclusion Criteria)

Inclusion Criteria:

  • Patients ≥18 and <70 years of age.
  • Active alcohol abuse defined according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) and excessive alcohol consumption prior to admission (> 60 g per day for men and> 40 g per day for women).
  • Moderate elevation of aminotransferases (usually less than 300 U / L) with a characteristic pattern of AST/ ALT ratio of 2:1.
  • Elevated serum GGT and bilirubin levels.
  • Absence of prior autoimmune liver disease (ANA<1/80, SMA<1/80, LKM1 neg, AMA neg).
  • Absence of hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIV neg).
  • Patients with decompensated alcoholic cirrhosis will be suitable for inclusion (eg, acute gastrointestinal bleeding, acute renal failure, hepatic encephalopathy and bacterial infections).
  • 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:
  • Steatosis (either macro or microvesicular).
  • Hepatocellular damage (eg, hepatocyte ballooning and presence of Mallory-Denk bodies).
  • Inflammatory infiltrate (predominantly polymorphonuclear cells).
  • Pericellular or sinusoidal fibrosis.

Exclusion Criteria:

  • Hepatocellular carcinoma.
  • Complete portal vein thrombosis.
  • Advanced or terminal extrahepatic diseases (eg heart failure, advanced lung diseases, advanced oncologic diseases).
  • Lack of consent to participate in the study.
  • Pregnancy.

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States