Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis

PHASE2CompletedINTERVENTIONAL
Enrollment

147

Participants

Timeline

Start Date

July 10, 2020

Primary Completion Date

May 24, 2022

Study Completion Date

August 12, 2022

Conditions
Alcoholic Hepatitis
Interventions
DRUG

Anakinra and Zinc

Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.

DRUG

Prednisone

Prednisone is indicated for numerous conditions including inflammatory disease. Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.

DRUG

Placebos

Matching placebo

Trial Locations (10)

15260

University of Pittsburgh, Pittsburgh

23284

Virginia Commonwealth University, Richmond

32224

Mayo Clinic, Jacksonville

40292

University of Louisville, Louisville

44195

Cleveland Clinic, Cleveland

55902

Mayo Clinic, Rochester

75390

University of Texas Southwestern Medical School, Dallas

85054

Mayo Clinic, Phoenix

46202-2879

Indiana Universtiy, Indianapolis

01003

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

lead

Indiana University

OTHER

NCT04072822 - Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis | Biotech Hunter | Biotech Hunter