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Indiana University School of Medicine
Indiana University School of Medicine
Studies

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

4910-Chalasani, Naga

Naga P. Chalasani, MD

David W. Crabb Professor of Gastroenterology and Hepatology

5172-Gawrieh, Samer

Samer Gawrieh, MD

Professor of Clinical Medicine

4795-Liangpunsakul, Suthat

Suthat Liangpunsakul, MD, MPH

Professor of Medicine

5034-Vuppalanchi, Raj

Raj Vuppalanchi, MD

Professor of 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

  • TREAT 001: Alcohol Hepatitis Observational Study

    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.

  • TREAT 002: Intercept Moderately Severe Alcoholic Hepatitis

    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

  • TREAT 003: Immuron Severe Alcoholic Hepatitis

    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

  • TREAT 008: An Open-label, Cohort Dose Escalation Study to Assess the Safety and Efficacy Signals of F-652 in Patients with Alcoholic Hepatitis

    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

  • AlcHepNet - 02
    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