Alcoholic Hepatitis 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.
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AlcHepNet - 01 (Alcoholic Hepatitis Network Observational Study)
Enrolling: Yes
Principle Investigator: Dr. Naga Chalasani
Duration: 5 years
Primary Outcomes Measured: To collect and store clinical data to facilitate investigations of th eepidemiology, 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
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Contact:
Savannah Yarnelle
(317) 278-6424
samussel@iu.edu |
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AlcHepNet - 02
Enrolling: Yes
Principle Investigator: Dr. Naga Chalasani
Duration: 5 years
Patient Population: Alcoholic hepatitis, healthy controls, and healthy heavy drinkers.
Drug(s): Anakinra/Zinc Sulfate, G-CSF, and Prednisone.
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Contact:
Savannah Yarnelle
(317) 278-6424
samussel@iu.edu |
Closed Studies:
TREAT 001: Alcohol Hepatitis Observational Study
Enrolling: No
Primary Investigator: Dr. Naga Chalasani
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
Primary Investigator: Dr. Naga Chalasani
Duration: 6 months
Primary Outcomes measured: Change in MELD score at 6 months; incidence of serious adverse events
Drug(s): obeticholic acid table or placebo
TREAT 003: Immuron Severe Alcoholic Hepatitis
Enrolling: No
Primary Investigator: Dr. Suthat Liangpunsakul
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
Primary Investigator: Dr. Raj Vuppalanchi
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