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Phase Pilot

Digoxin In Alcohol Associated Hepatitis

  • Study HIC#:2000030659
  • Last Updated:11/11/2022

Acute alcohol associated hepatitis (also known as AlcHep) is an illness that results from alcohol consumption. Patients with the severe form of AlcHep have up to 40% mortality within 6 months after diagnosis. There are no approved drugs to treat AlcHep. Pre-clinical studies show that digoxin, a drug currently used in the treatment of heart failure and other heart conditions, can improve liver injury associated with alcohol use. The main goal of this study is to assess the feasibility of conducting a future large clinical trial with respect to patient recruitment, digoxin administration and dose adjustment in patients admitted to the hospital with severe AlcHep.

  • Age21 years - 65 years
  • GenderBoth
  • Start Date10/12/2021
  • End Date02/28/2023

Trial Purpose and Description

Acute alcohol associated hepatitis (also known as AlcHep) is an illness that results from alcohol consumption. Patients with the severe form of AlcHep have up to 40% mortality within 6 months after diagnosis. There are no approved drugs to treat AlcHep. Pre-clinical studies show that digoxin, a drug currently used in the treatment of heart failure and other heart conditions, can improve liver injury associated with alcohol use. The main goal of this study is to assess the feasibility of conducting a future large clinical trial with respect to patient recruitment, digoxin administration and dose adjustment in patients admitted to the hospital with severe AlcHep.

Eligibility Criteria

Inclusion Criteria:

  1. Diagnosis of alcohol associated hepatitis based on clinical criteria or histologic evidence
    1. Clinical criteria:
      • Onset of jaundice (bilirubin >3 mg/dL) within the prior 8 weeks
      • 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
      • AST > 50 IU/l
      • AST: ALT > 1.5 and both values < 400 IU/l
    2. Histological evidence of alcohol associated hepatitis*
  2. MDF 32 to 60 or MELD 20 to 30 on Day 0 of the trial
  3. Started on steroid treatment for acute alcohol associated hepatitis
  4. Age between 21 and 65 years, inclusive

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
  • History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic hemochromatosis, alpha1-antitrypsin deficiency, strong suspicion for Drug Induced Liver Injury (DILI), or other etiologies seen on liver imaging
  • History of HIV infection (positive HIV RNA or on treatment for HIV infection)
  • Current diagnosis of cancer
  • Renal failure defined by GFR <30 mL/min
  • Refractory ascites, defined as having more than 4 paracenteses in the preceding 8 weeks despite diuretic therapy
  • Prior exposure to experimental therapies or other clinical trial in last 3 months
  • Current acute or chronic pancreatitis
  • Active gastrointestinal bleeding unless resolved for >48 hours
  • Experiencing withdrawal seizures or considered at high risk for alcohol withdrawal seizures or delirium tremens
  • Heart rate less than 60 bpm at screening visit or at baseline
  • Current diagnosis of atrial fibrillation
  • Cardiomyopathy
  • Heart failure
  • Severe aortic valve disease
  • Presence of Accessory arterio-ventricular pathway (eg Wolf-Parkinson-White syndrome)
  • Complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device
  • Any of the following within the previous 6 months: myocardial infarction, percutaneous intervention, pacemaker/implantable cardiac device implantation, cardiac surgery or stroke
  • Current use of the following medications: Antiarrthymics (amiodarone, dofetilide, sotalol, dronedarone), Parathyroid hormone analog (teriparatide), Thyroid supplement (thyroid), Sympathomimetics or ionotropic drugs (epinephrine, norepinephrine, dopamine, dobutamine, milrinone), Neuromuscular blocking agents (succinylcholine), Calcium supplement, Ivabradine, Disulfiram

Sub-Investigators

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