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
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
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.
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.
