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Physician-scientists at IU School of Medicine conduct ground-breaking liver research to understand alcoholic hepatitis.

Alcoholic Hepatitis Research Studies

Alcoholic hepatitis is a reaction of the liver to years of heavy drinking. Inflammation from hepatitis may also cause scar tissue to form. Alcoholic hepatitis may cause a spectrum of problems, ranging from mild abnormalities in liver tests to serious illness requiring hospitalization and a substantial risk of death.

Investigators

Naga P. Chalasani, MD

David W. Crabb Professor of Gastroenterology and Hepatology

Samer Gawrieh, MD

Professor of Clinical Medicine

Open Research Studies for Alcoholic Hepatitis

AlcHepNet - 01 (Alcoholic Hepatitis Network Observational Study)

Enrolling: Yes

Principle Investigator: Naga Chalasani, MD 

Duration: 5 years

Primary Outcomes Measured: To collect and store clinical data to facilitate investigations of the epidemiology, diagnosis, pathophysiology, natural history, and treatment of alcoholic hepatitis.

Secondary Outcomes Measured: To develop a bio-specimen bank comprised of plasma, DNA, and other biological specimens obtained from patients with alcoholic hepatitis, heavy drinkers without clinical liver disease, and healthy subjects to support translational research in the pathophysiology of alcoholic hepatitis.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

Closed Alcoholic Hepatitis Studies

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: 1 year

Primary Outcomes Measured: Developing a repository of biological samples from AH patients and heavy drinking controls.

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: 6 months

Primary Outcomes Measured: Change in MELD score at 6 months; incidence of serious adverse events.

Drug(s): Obeticholic acid tablet or placebo

Enrolling: No

Principle Investigator: Suthat Liangpunsakul, MD

Duration: 6 months

Primary Outcomes Measured: Greater decrease in mean ciculating levels in those receiving Steroids+ Imm 124-E compared to steroids + placebo

Drug(s)IMM123-E(Bovine Colostrum Drug Substance or BCDS) or Placebo

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: Study drug infusions on days 1 and 7, follow-up phase day 8 to 42.

Primary Outcomes Measured: Absence of unexpected serious adverse events.

Drug(s): F-652 infusion, 10 μg/kg, 30 μg/kg or 45 μg/kg

Enrolling: No

Principle Investigator: Naga Chalasani, MD 

Duration: 5 years

Primary Outcomes Measured: To collect and store clinical data to facilitate investigations of the epidemiology, diagnosis, pathophysiology, natural history, and treatment of alcoholic hepatitis.

Secondary Outcomes Measured: To develop a bio-specimen bank comprised of plasma, DNA, and other biological specimens obtained from patients with alcoholic hepatitis, heavy drinkers without clinical liver disease, and healthy subjects to support translational research in the pathophysiology of alcoholic hepatitis.

View the study on clinicaltrials.gov

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: 5 years

Patient Population: Alcoholic hepatitis, healthy controls, and healthy heavy drinkers.

Drugs: Anakinra/Zinc Sulfate, G-CSF, and Prednisone.

View the study on clinicaltrials.gov