RECRUITING

Digoxin In Treatment of Alcohol Associated Hepatitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Digoxin In Treatment of Alcohol Associated Hepatitis (DIGIT-AlcHep)

Quick Facts

Study Start:2021-10-08
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05014087

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of alcohol associated hepatitis based on clinical criteria or histologic evidence
  2. 1. Clinical criteria:
  3. * Onset of jaundice (bilirubin \>3 mg/dL) within the prior 8 weeks
  4. * Regular alcohol use \> 6 months, with intake of \> 40 g/day (\>280 g/week) for women; and \> 60 g/day (\>420 g/week) for men
  5. * AST \> 50 IU/l
  6. * AST: ALT \> 1.5 and both values \< 400 IU/l
  7. 2. Histological evidence of alcohol associated hepatitis\*
  8. 2. MDF \>32 or MELD ≥ 20 to ≤ 35 on Day 0 of the trial
  9. 3. Age between 21 and 70 years, inclusive
  1. 1. - Currently pregnant or breastfeeding
  2. 2. - Inability of patient, legally authorized representative or next-of-kin to provide informed consent
  3. 3. - Allergy or intolerance to digoxin
  4. 4. - Clinically active C. diff infection
  5. 5. - Positive test for COVID-19 within 14 days prior to the screening visit
  6. 6. - Acute hepatitis E, Cytomegalovirus, Epstein Barr Virus, Herpes Simplex Virus
  7. * Antiarrhythmic (amiodarone, dofetilide, sotalol, dronedarone)
  8. * Parathyroid hormone analog (teriparatide)
  9. * Thyroid supplement (thyroid, levothyroxine sodium)
  10. * Sympathomimetics or ionotropic drugs (epinephrine, norepinephrine, dopamine, dobutamine, milrinone)
  11. * Neuromuscular blocking agents (succinylcholine)
  12. * Calcium supplement
  13. * Ivabradine
  14. * Disulfiram

Contacts and Locations

Study Contact

Bubu Banini, MD, PhD
CONTACT
203-737-6063
bubu.banini@yale.edu
Camalene Chrysostoum
CONTACT
camalene.chrysostoum@yale.edu

Principal Investigator

Bubu Banini, MD, PhD
PRINCIPAL_INVESTIGATOR
Yale School of Medicine

Study Locations (Sites)

Yale New Haven Hospital, Yale School of Medicine
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Bubu Banini, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-08
Study Completion Date2025-04

Study Record Updates

Study Start Date2021-10-08
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • Acute alcoholic hepatitis
  • Liver injury
  • Liver inflammation
  • Liver disease
  • Digoxin

Additional Relevant MeSH Terms

  • Acute Alcoholic Hepatitis
  • Chemical and Drug Induced Liver Injury
  • Alcohol-Induced Disorders
  • Steatohepatitis Caused by Ingestible Alcohol