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Alcoholic Hepatitis Research Studies

Alcoholic hepatitis is a reaction is a reaction of the liver to years of heavy drinking. It 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

Interim Chair, Department of Medicine

Samer Gawrieh, MD

Associate Professor of Clinical Medicine

Suthat Liangpunsakul, MD

Professor of Medicine

Raj Vuppalanchi, MB,BS

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 coordinator below:
Jennifer Lehman
jgeck@iu.edu
(317) 278-1872

View the study on clinicaltrials.gov

AlcHepNet - 02

Enrolling: Yes

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.

Interested in this study? Please contact the coordinator below:
Jennifer Lehman
jgeck@iu.edu
(317) 278-1872

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 Sever 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