Acute Alcoholic HepatitisPhase 2DIGIT-AlcHepNCT05014087
Digoxin In Treatment of Alcohol Associated Hepatitis
A Phase 2 study testing Intravenous digoxin in people with Acute Alcoholic Hepatitis and Chemical and Drug Induced Liver Injury, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Acute Alcoholic Hepatitis, Chemical and Drug Induced Liver Injury, Alcohol-Induced Disorders
- What is being tested?
- Intravenous digoxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 12 Sep 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Diagnosis of alcohol associated hepatitis based on clinical criteria or histologic evidence
- 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
Show all 11Show fewer
- 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.
Who cannot join
- - 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
Show all 33Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital, Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Digoxin In Treatment of Alcohol Associated Hepatitis (DIGIT-AlcHep)
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.
Read the detailed description
Severe alcohol associated hepatitis is a condition of acute on chronic immune liver dysfunction that is associated with high mortality, necessitating a search for drugs that may prove safe and efficacious in treating this disease. Pre-clinical studies suggest that digoxin, which is currently used for treating cardiac conditions, is also effective in improving alcohol-associated liver injury. To date, there have been no clinical studies of digoxin use in patients with alcohol associated hepatitis.
The primary objective of this randomized control study of digoxin versus no digoxin in patients with severe alcohol associated hepatitis is to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients hospitalized with severe alcohol associated hepatitis.
- Conditions
- Acute Alcoholic Hepatitis, Chemical and Drug Induced Liver Injury, Alcohol-Induced Disorders, Steatohepatitis Caused by Ingestible Alcohol
- Being tested
- Intravenous digoxin
- Keywords
- Acute alcoholic hepatitis, Liver injury, Liver inflammation, Liver disease, Digoxin
- Medical subject headings
- Chemical and Drug Induced Liver Injury, Alcohol-Induced Disorders, Fatty Liver, Alcoholic, Hepatitis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous digoxinDrug
Also called Lanoxin
Loading dose: the total loading dose of digoxin will be determined using the Loading nomogram. The FDA-recommended total IV digoxin loading dose range is 8 to 12 mcg/kg. The lowest recommended dose of 8 mcg/kg was used in constructing the digoxin Loading nomogram that will be used in this trial.
Maintenance dose: the maintenance dose will be started approximately 24 hours after initiation of digoxin loading. The post-loading digoxin trough will be reviewed prior to starting maintenance dosing.
Subjects on P-gp inhibitors or spironolactone, will have an additional digoxin level performed 12-hours after any dose adjustment. Once digoxin levels are stable, 24-hour blood draws will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Digoxin | Experimental | In the digoxin arm, the intervention to be administered will be intravenous digoxin dosed by weight and by renal function using an adaption of the established FDA nomogram. Participants randomized to digoxin will receive an intravenous digoxin loading dose administered in 3 doses over 24 hours starting on Day 1. Digoxin levels will be monitored daily throughout the participant's hospital stay, to a maximum of 28 days. Digoxin will be discontinued at the time discharge if before 28 days. Receives: Drug: Intravenous digoxin |
| Arm B: No Digoxin | No intervention | In the no digoxin arm, no study drug or placebo will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biomarkers of Inflammation
Change in IL-6, IL-10 and TNF-alpha levels (pg/ml) at day 3 in participants with acute alcohol associated hepatitis treated with digoxin vs no digoxin.
Measured: Day 3
Secondary outcomes (6)
Practicality of Daily Digoxin Measurements
Practicality of daily digoxin measurements is recorded at the participant level as the proportion of timepoints where serum digoxin levels are checked within the pre-specified time window. It is summarized and reported as the mean and standard deviation of the proportion of eligible timepoints.
Measured: From Day 2 to Day 28 or until discharge, whichever sooner
Feasibility of Digoxin Dosing in a Timely Manner.
Feasibility of digoxin dosing is recorded at the participant level as the proportion of eligible timepoints where the scheduled digoxin dose was given. It is summarized and reported as the mean and standard deviation of the proportion of scheduled timepoints.
Measured: From Day 1 to Day 28 or until discharge, whichever sooner
Feasibility of Digoxin Dose Adjustments in Renal Insufficiency.
Feasibility of digoxin dose adjustments in renal insufficiency is recorded at the participant level as the proportion of timepoints where necessary dose adjustments were made appropriately in response to digoxin levels. Renal insufficiency was defined as a creatinine rise ≥ 0.3 mg/dL over 48 hours or ≥ 20% from baseline or requiring renal replacement therapy. It is reported as the mean and standard deviation of the proportion of timepoints.
Measured: From Day 0 to Day 28 or until discharge, whichever sooner
Mortality at 7, 14, 28, 90 Days. All Cause Mortality of Patients Enrolled in the Trial.
The mortality rates at different time points
Measured: Day 7, Day 14, Day 28, and Day 90
Development of Arrhythmia
It refers to any type of arrhythmia which represents a change from baseline. It is reported as the proportion of individuals who developed an arrhythmia.
Measured: From Day 0 to Day 28 or until discharge, whichever sooner
Recruitment
Ability to recruit 4 patients per month to reach anticipated enrollment of 60. Data presented here is the number participants enrolled.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start8 Oct 2021
- Primary completion22 Jun 2025
- Study completion12 Sep 2025
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Acute Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single center, open label, randomized 1:1 controlled trial.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bubu Banini, MD, PhD, Yale University
- Investigators
- Bubu Banini, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014087
- Sponsor's protocol ID
- 2000030659
- Acronym
- DIGIT-AlcHep
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2021
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maddrey WC, Boitnott JK, Bedine MS, Weber FL Jr, Mezey E, White RI Jr. Corticosteroid therapy of alcoholic hepatitis. Gastroenterology. 1978 Aug;75(2):193-9.
PubMed 352788Sahlman P, Nissinen M, Pukkala E, Farkkila M. Incidence, survival and cause-specific mortality in alcoholic liver disease: a population-based cohort study. Scand J Gastroenterol. 2016 Aug;51(8):961-6. doi: 10.3109/00365521.2016.1157889. Epub 2016 May 16.
PubMed 27181618Thursz MR, Richardson P, Allison M, Austin A, Bowers M, Day CP, Downs N, Gleeson D, MacGilchrist A, Grant A, Hood S, Masson S, McCune A, Mellor J, O'Grady J, Patch D, Ratcliffe I, Roderick P, Stanton L, Vergis N, Wright M, Ryder S, Forrest EH; STOPAH Trial. Prednisolone or pentoxifylline for alcoholic hepatitis. N Engl J Med. 2015 Apr 23;372(17):1619-28. doi: 10.1056/NEJMoa1412278.
PubMed 25901427Scalese MJ, Salvatore DJ. Role of Digoxin in Atrial Fibrillation. J Pharm Pract. 2017 Aug;30(4):434-440. doi: 10.1177/0897190016642361. Epub 2016 Apr 10.
PubMed 27067743Ouyang X, Han SN, Zhang JY, Dioletis E, Nemeth BT, Pacher P, Feng D, Bataller R, Cabezas J, Starkel P, Caballeria J, Pongratz RL, Cai SY, Schnabl B, Hoque R, Chen Y, Yang WH, Garcia-Martinez I, Wang FS, Gao B, Torok NJ, Kibbey RG, Mehal WZ. Digoxin Suppresses Pyruvate Kinase M2-Promoted HIF-1alpha Transactivation in Steatohepatitis. Cell Metab. 2018 Feb 6;27(2):339-350.e3. doi: 10.1016/j.cmet.2018.01.007.
PubMed 29414684Arteel GE, Iimuro Y, Yin M, Raleigh JA, Thurman RG. Chronic enteral ethanol treatment causes hypoxia in rat liver tissue in vivo. Hepatology. 1997 Apr;25(4):920-6. doi: 10.1002/hep.510250422.
PubMed 9096598Lee YS, Kim JW, Osborne O, Oh DY, Sasik R, Schenk S, Chen A, Chung H, Murphy A, Watkins SM, Quehenberger O, Johnson RS, Olefsky JM. Increased adipocyte O2 consumption triggers HIF-1alpha, causing inflammation and insulin resistance in obesity. Cell. 2014 Jun 5;157(6):1339-1352. doi: 10.1016/j.cell.2014.05.012.
PubMed 24906151Nath B, Levin I, Csak T, Petrasek J, Mueller C, Kodys K, Catalano D, Mandrekar P, Szabo G. Hepatocyte-specific hypoxia-inducible factor-1alpha is a determinant of lipid accumulation and liver injury in alcohol-induced steatosis in mice. Hepatology. 2011 May;53(5):1526-37. doi: 10.1002/hep.24256.
PubMed 21520168Palmer BF, Clegg DJ. Ascent to altitude as a weight loss method: the good and bad of hypoxia inducible factor activation. Obesity (Silver Spring). 2014 Feb;22(2):311-7. doi: 10.1002/oby.20499. Epub 2013 Oct 15.
PubMed 23625659Semenza GL. Hypoxia-inducible factors in physiology and medicine. Cell. 2012 Feb 3;148(3):399-408. doi: 10.1016/j.cell.2012.01.021.
PubMed 22304911Hollman A. Drugs for atrial fibrillation. Digoxin comes from Digitalis lanata. BMJ. 1996 Apr 6;312(7035):912. doi: 10.1136/bmj.312.7035.912. No abstract available.
PubMed 8611904Digoxin FDA insert. . [cited 2021 3/15/2021]
(CDC)., C.f.D.C.a.P. Alcohol and Public Health: Alcohol-Related Disease Impact (ARDI). Annual Average for United States 2011-2015 Alcohol-Attributable Deaths Due to Excessive Alcohol Use, All Ages. [cited 2021 3/20/2021]
(NIH)., N.I.o.H. Alcohol Facts and Statistics. [cited 2021 3/20/2021]
Rathore SS, Curtis JP, Wang Y, Bristow MR, Krumholz HM. Association of serum digoxin concentration and outcomes in patients with heart failure. JAMA. 2003 Feb 19;289(7):871-8. doi: 10.1001/jama.289.7.871.
PubMed 12588271
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digoxin In Treatment of Alcohol Associated Hepatitis (DIGIT-AlcHep)
- ClinicalTrials.gov ID
- NCT05014087
- Acronym / sponsor ID
- DIGIT-AlcHep / 2000030659
- Conditions
- Acute Alcoholic Hepatitis, Chemical and Drug Induced Liver Injury, Alcohol-Induced Disorders, Steatohepatitis Caused by Ingestible Alcohol
- Keywords
- Acute alcoholic hepatitis, Liver injury, Liver inflammation, Liver disease, Digoxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe alcohol associated hepatitis is a condition of acute on chronic immune liver dysfunction that is associated with high mortality, necessitating a search for drugs that may prove safe and efficacious in treating this disease. Pre-clinical studies suggest that digoxin, which is currently used for treating cardiac conditions, is also effective in improving alcohol-associated liver injury. To date, there have been no clinical studies of digoxin use in patients with alcohol associated hepatitis.
The primary objective of this randomized control study of digoxin versus no digoxin in patients with severe alcohol associated hepatitis is to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients hospitalized with severe alcohol associated hepatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single center, open label, randomized 1:1 controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Digoxin | Experimental | Drug: Intravenous digoxinIn the digoxin arm, the intervention to be administered will be intravenous digoxin dosed by weight and by renal function using an adaption of the established FDA nomogram. Participants randomized to digoxin will receive an intravenous digoxin loading dose administered in 3 doses over 24 hours starting on Day 1. Digoxin levels will be monitored daily throughout the participant's hospital stay, to a maximum of 28 days. Digoxin will be discontinued at the time discharge if before 28 days. |
| Arm B: No Digoxin | No intervention | –In the no digoxin arm, no study drug or placebo will be administered. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Diagnosis of alcohol associated hepatitis based on clinical criteria or histologic evidence
- Clinical criteria:
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous digoxinAlso: LanoxinLoading dose: the total loading dose of digoxin will be determined using the Loading nomogram. The FDA-recommended total IV digoxin loading dose range is 8 to 12 mcg/kg. The lowest recommended dose of 8 mcg/kg was used in constructing the digoxin Loading nomogram that will be used in this trial. Maintenance dose: the maintenance dose will be started approximately 24 hours after initiation of digoxin loading. The post-loading digoxin trough will be reviewed prior to starting maintenance dosing. Subjects on P-gp inhibitors or spironolactone, will have an additional digoxin level performed 12-hours after any dose adjustment. Once digoxin levels are stable, 24-hour blood draws will be performed. | Drug | Arm A: Digoxin |
Primary outcome
Change in Biomarkers of Inflammation
Time frame: Day 3
Change in IL-6, IL-10 and TNF-alpha levels (pg/ml) at day 3 in participants with acute alcohol associated hepatitis treated with digoxin vs no digoxin.
6 secondary outcomes
Practicality of Daily Digoxin Measurements
Time frame: From Day 2 to Day 28 or until discharge, whichever sooner
Feasibility of Digoxin Dosing in a Timely Manner.
Time frame: From Day 1 to Day 28 or until discharge, whichever sooner
Feasibility of Digoxin Dose Adjustments in Renal Insufficiency.
Time frame: From Day 0 to Day 28 or until discharge, whichever sooner
Mortality at 7, 14, 28, 90 Days. All Cause Mortality of Patients Enrolled in the Trial.
Time frame: Day 7, Day 14, Day 28, and Day 90
Development of Arrhythmia
Time frame: From Day 0 to Day 28 or until discharge, whichever sooner
Recruitment
Time frame: up to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 352788Maddrey WC, Boitnott JK, Bedine MS, Weber FL Jr, Mezey E, White RI Jr. Corticosteroid therapy of alcoholic hepatitis. Gastroenterology. 1978 Aug;75(2):193-9.
- Background: PubMed 27181618Sahlman P, Nissinen M, Pukkala E, Farkkila M. Incidence, survival and cause-specific mortality in alcoholic liver disease: a population-based cohort study. Scand J Gastroenterol. 2016 Aug;51(8):961-6. doi: 10.3109/00365521.2016.1157889. Epub 2016 May 16.
- Background: PubMed 25901427Thursz MR, Richardson P, Allison M, Austin A, Bowers M, Day CP, Downs N, Gleeson D, MacGilchrist A, Grant A, Hood S, Masson S, McCune A, Mellor J, O'Grady J, Patch D, Ratcliffe I, Roderick P, Stanton L, Vergis N, Wright M, Ryder S, Forrest EH; STOPAH Trial. Prednisolone or pentoxifylline for alcoholic hepatitis. N Engl J Med. 2015 Apr 23;372(17):1619-28. doi: 10.1056/NEJMoa1412278.
- Background: PubMed 27067743Scalese MJ, Salvatore DJ. Role of Digoxin in Atrial Fibrillation. J Pharm Pract. 2017 Aug;30(4):434-440. doi: 10.1177/0897190016642361. Epub 2016 Apr 10.
- Background: PubMed 29414684Ouyang X, Han SN, Zhang JY, Dioletis E, Nemeth BT, Pacher P, Feng D, Bataller R, Cabezas J, Starkel P, Caballeria J, Pongratz RL, Cai SY, Schnabl B, Hoque R, Chen Y, Yang WH, Garcia-Martinez I, Wang FS, Gao B, Torok NJ, Kibbey RG, Mehal WZ. Digoxin Suppresses Pyruvate Kinase M2-Promoted HIF-1alpha Transactivation in Steatohepatitis. Cell Metab. 2018 Feb 6;27(2):339-350.e3. doi: 10.1016/j.cmet.2018.01.007.
- Background: PubMed 9096598Arteel GE, Iimuro Y, Yin M, Raleigh JA, Thurman RG. Chronic enteral ethanol treatment causes hypoxia in rat liver tissue in vivo. Hepatology. 1997 Apr;25(4):920-6. doi: 10.1002/hep.510250422.
- Background: PubMed 24906151Lee YS, Kim JW, Osborne O, Oh DY, Sasik R, Schenk S, Chen A, Chung H, Murphy A, Watkins SM, Quehenberger O, Johnson RS, Olefsky JM. Increased adipocyte O2 consumption triggers HIF-1alpha, causing inflammation and insulin resistance in obesity. Cell. 2014 Jun 5;157(6):1339-1352. doi: 10.1016/j.cell.2014.05.012.
- Background: PubMed 21520168Nath B, Levin I, Csak T, Petrasek J, Mueller C, Kodys K, Catalano D, Mandrekar P, Szabo G. Hepatocyte-specific hypoxia-inducible factor-1alpha is a determinant of lipid accumulation and liver injury in alcohol-induced steatosis in mice. Hepatology. 2011 May;53(5):1526-37. doi: 10.1002/hep.24256.
- Background: PubMed 23625659Palmer BF, Clegg DJ. Ascent to altitude as a weight loss method: the good and bad of hypoxia inducible factor activation. Obesity (Silver Spring). 2014 Feb;22(2):311-7. doi: 10.1002/oby.20499. Epub 2013 Oct 15.
- Background: PubMed 22304911Semenza GL. Hypoxia-inducible factors in physiology and medicine. Cell. 2012 Feb 3;148(3):399-408. doi: 10.1016/j.cell.2012.01.021.
- Background: PubMed 8611904Hollman A. Drugs for atrial fibrillation. Digoxin comes from Digitalis lanata. BMJ. 1996 Apr 6;312(7035):912. doi: 10.1136/bmj.312.7035.912. No abstract available.
- BackgroundDigoxin FDA insert. . [cited 2021 3/15/2021]
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bubu Banini, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous digoxin in people with Acute Alcoholic Hepatitis and Chemical and Drug Induced Liver Injury, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Biomarkers of Inflammation (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05014087, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.