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Cardiac Glycoside

Digoxin for Alcoholic Hepatitis (DIGIT-AlcHep Trial)

Phase 2

Recruiting

Led By Bubu Banini, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 21 and 70 years, inclusive

Diagnosis of alcohol associated hepatitis based on clinical criteria or histologic evidence

Must not have

- Antiarrhythmic (amiodarone, dofetilide, sotalol, dronedarone)

History of HIV infection (positive HIV RNA or on treatment for HIV infection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a drug called digoxin is effective at treating people with severe alcohol-related liver damage. Patients will be given the drug or a placebo and monitored to see if their liver damage improves.

Who is the study for?

Adults aged 21-70 with severe acute alcohol-associated hepatitis can join this trial. They must have a history of regular heavy drinking and specific blood test results indicating liver damage. Excluded are pregnant or breastfeeding individuals, those allergic to digoxin, with certain infections including COVID-19, other liver diseases, HIV, cancer, serious heart conditions or on conflicting medications.

What is being tested?

The study is testing if intravenous digoxin is safe and effective for treating severe acute alcoholic hepatitis compared to no treatment. Participants will be randomly assigned to receive either digoxin (with doses adjusted based on kidney function) or no digoxin in an open-label format for up to 28 days.

What are the potential side effects?

Potential side effects of digoxin may include nausea, vomiting, dizziness, fatigue, confusion and changes in heartbeat rhythm. Since it's used here for liver disease patients who often have complex health issues already present due to their condition and alcohol use history.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 70 years old.

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I have been diagnosed with hepatitis related to alcohol use.

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My liver damage is due to alcohol use.

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I have recently developed jaundice, drink heavily, and have specific liver enzyme levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any specific heart rhythm medications.

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I am HIV positive or currently being treated for HIV.

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I am taking a medication called teriparatide.

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I have a serious heart block without a pacemaker.

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I am currently diagnosed with cancer.

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I do not have active hepatitis E, CMV, EBV, or HSV infections.

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I have a history of liver diseases such as hepatitis B or C, autoimmune hepatitis, Wilson disease, genetic hemochromatosis, or alpha1-antitrypsin deficiency.

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I have been diagnosed with liver injury caused by medication or seen in liver scans.

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I am currently experiencing pancreatitis.

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I have been diagnosed with atrial fibrillation.

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I am currently suffering from an active C. diff infection.

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I am allergic or intolerant to digoxin.

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I have been diagnosed with cardiomyopathy.

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I have heart failure.

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I have had more than 4 fluid removal procedures from my abdomen in the last 8 weeks despite taking water pills.

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I have a serious heart valve problem.

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I have an extra electrical pathway in my heart (like Wolf-Parkinson-White syndrome).

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I cannot give consent for medical procedures myself.

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My kidney function is very low.

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I am not taking muscle relaxants like succinylcholine.

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I am not taking any heart-stimulating medications like epinephrine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in biomarkers of inflammation

Secondary study objectives

Electrocardiogram

Feasibility of digoxin dose adjustments in renal insufficiency.

Feasibility of digoxin dosing in a timely manner.

+3 more

Other study objectives

Development of new or recurrent renal failure.

Organ Dysfunction (Multi-Organ) with Sequential Organ Failure Assessment (SOFA)

Organ Dysfunction (Multi-Organ) with the Multi-Organ Dysfunction Score (MODS)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: DigoxinExperimental Treatment1 Intervention

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.

Group II: Arm B: No DigoxinActive Control1 Intervention

In the no digoxin arm, no study drug or placebo will be administered.

0 / 25Eligibility criteria met