Heart drug digoxin tested for alcoholic hepatitis – early trial halted

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 or MELD ≥ 20 to ≤ 35 on Day 0 of the trial 3\. Age between 21 and 70 years, inclusive \* In patients with possible alcohol associated hepatitis with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use, or atypical/abnormal laboratory tests (e.g., AST \< 50 IU/IU/L or \> 400 IU/IU/L, AST/ALT ratio \< 1.5), antinuclearantibody \> 1:160 or SMA \> 1:80, standard of care liver biopsy may be performed as per discretion of the primary attending physician to confirm alcohol associated hepatitis and exclude competing etiologies. The decision to perform liver biopsy will be made by the primary team and will occur regardless of the study. As per current SOC, a liver biopsy may be obtained to confirm suspected alcohol-associated hepatitis and to rule out other potential etiologies of liver disease. If a liver biopsy is performed for clinically indicated reasons, we will store liver tissue that is left over after the portion needed for the primary indication has been identified. Exclusion Criteria: 1. \- Currently pregnant or breastfeeding 2. \- Inability of patient, legally authorized representative or next-of-kin to provide informed consent 3. \- Allergy or intolerance to digoxin 4. \- Clinically active C. diff infection 5. \- Positive test for COVID-19 within 14 days prior to the screening visit 6. \- Acute hepatitis E, Cytomegalovirus, Epstein Barr Virus, Herpes Simplex Virus 7- History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis 8-C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic hemochromatosis, alpha1-antitrypsin deficiency. 8-Diagnosis of Drug Induced Liver Injury (DILI), or other etiologies seen on liver imaging. 9 - History of HIV infection (positive HIV RNA or on treatment for HIV infection) 10 - Current diagnosis of cancer 11- Renal failure defined by GFR \<30 mL/min 12 - Refractory ascites, defined as having more than 4 paracenteses in the preceding 8 weeks despite diuretic therapy 13 - Prior exposure to experimental therapies or other clinical trial in last 3 months 14 - Current acute or chronic pancreatitis 15 - Active gastrointestinal bleeding unless resolved for \>48 hours 16 - Experiencing withdrawal seizures or considered at high risk for alcohol withdrawal seizures or delirium tremens 17 - Heart rate less than 60 bpm at screening visit or at baseline 18 - Current diagnosis of atrial fibrillation 19 - Cardiomyopathy 20 - Heart failure 21 - Severe aortic valve disease 22 - Presence of Accessory arterio-ventricular pathway (eg Wolf-Parkinson-White syndrome) 23 - Complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device 24 - Any of the following within the previous 6 months: myocardial infarction, percutaneous intervention, pacemaker/implantable cardiac device implantation, cardiac surgery or stroke 25 - Current use of the following medications: * Antiarrhythmic (amiodarone, dofetilide, sotalol, dronedarone) * Parathyroid hormone analog (teriparatide) * Thyroid supplement (thyroid, levothyroxine sodium) * Sympathomimetics or ionotropic drugs (epinephrine, norepinephrine, dopamine, dobutamine, milrinone) * Neuromuscular blocking agents (succinylcholine) * Calcium supplement * Ivabradine * Disulfiram