TerminatedPhase 2

Digoxin In Treatment of Alcohol Associated Hepatitis

Stopped: Slow accrual

United States23 participantsStarted 2021-10-08

Plain-language summary

Prospective, single center, open label, randomized controlled trial to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients with acute alcohol associated hepatitis, digoxin administration and dose adjustment. The study intervention will be intravenous digoxin (renal-based dosing for maximum of 28 days) versus no digoxin in an open-label 1:1 randomized allocation of patients with severe acute alcohol associated hepatitis.

Who can participate

Age range21 Years – 70 Years

SexALL

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Inclusion criteria

✓. Clinical criteria:
✓. Histological evidence of alcohol associated hepatitis\*

Exclusion criteria

✕. \- Currently pregnant or breastfeeding
✕. \- Inability of patient, legally authorized representative or next-of-kin to provide informed consent
✕. \- Allergy or intolerance to digoxin
✕. \- Clinically active C. diff infection
✕. \- Positive test for COVID-19 within 14 days prior to the screening visit
✕. \- Acute hepatitis E, Cytomegalovirus, Epstein Barr Virus, Herpes Simplex Virus

What they're measuring

Change in biomarkers of inflammation

Timeframe: day 3

Trial details

NCT IDNCT05014087

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-22

View on ClinicalTrials.gov More Acute Alcoholic Hepatitis trials