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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
DIGIT-AlcHep Trial 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.Check my eligibility
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.See study design
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.
DIGIT-AlcHep Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
DIGIT-AlcHep Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability to recruit 4 patients a month.
Secondary outcome measures
Electrocardiogram
Feasibility of digoxin dose adjustments in renal insufficiency.
Feasibility of digoxin dosing in a timely manner.
+2 moreOther outcome measures
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 moreDIGIT-AlcHep 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.
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,381 Total Patients Enrolled
Bubu Banini, MD, PhDPrincipal InvestigatorYale School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking specific medications.I am not taking any specific heart rhythm medications.I am HIV positive or currently being treated for HIV.I am taking a medication called teriparatide.I am between 21 and 70 years old.I have been diagnosed with hepatitis related to alcohol use.I am taking calcium supplements.My condition meets the specific clinical requirements.I have a serious heart block without a pacemaker.I am taking Ivabradine.My liver damage is due to alcohol use.I am currently diagnosed with cancer.I do not have active hepatitis E, CMV, EBV, or HSV infections.I have a history of liver diseases such as hepatitis B or C, autoimmune hepatitis, Wilson disease, genetic hemochromatosis, or alpha1-antitrypsin deficiency.I have been diagnosed with liver injury caused by medication or seen in liver scans.I have not had a heart attack, heart surgery, stroke, or any heart device implanted in the last 6 months.I am currently experiencing pancreatitis.I have been diagnosed with atrial fibrillation.I have recently developed jaundice, drink heavily, and have specific liver enzyme levels.I have not had any active bleeding from my stomach or intestines in the last 48 hours.I am currently suffering from an active C. diff infection.I am allergic or intolerant to digoxin.I have been diagnosed with cardiomyopathy.I have heart failure.I have had more than 4 fluid removal procedures from my abdomen in the last 8 weeks despite taking water pills.I have a serious heart valve problem.I have an extra electrical pathway in my heart (like Wolf-Parkinson-White syndrome).I am not taking disulfiram.I cannot give consent for medical procedures myself.My kidney function is very low.I am taking thyroid medication.I am not taking muscle relaxants like succinylcholine.I am not taking any heart-stimulating medications like epinephrine.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: No Digoxin
- Group 2: Arm A: Digoxin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to enroll in this clinical experiment?
"In order to partake in this clinical trial, individuals must be affected by hepatitis and have a toxic history between the ages of 21 and 65. The team is hoping to recruit 60 participants."
Answered by AI
Are there still openings available for patients to participate in this trial?
"According to the data hosted on clinicaltrials.gov, this medical survey is actively seeking participants; beginning from October 8th 2021 and having had its latest update on November 18th 2021."
Answered by AI
Does this research allow for the participation of youths aged below 25?
"Enrolment in this medical trial is restricted to those 21-65 years of age. However, there are 46 studies for younger patients and 411 for senior citizens."
Answered by AI
Has the FDA granted its seal of approval to Intravenous digoxin?
"Because it is a Phase 2 trial, indicating that there is an absence of data supporting efficacy but some information on safety, our team at Power has cautiously assessed the security of intravenous digoxin to be a score of 2."
Answered by AI
What medical concerns does Intravenous digoxin address?
"Intravenous digoxin has been clinically-proven to effectively address myocardial contractility, mild and moderate heart failure, as well as cardiac arrhythmia."
Answered by AI
What is the scope of participants receiving treatment in this research?
"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial is open - it was first posted on October 8th 2021 and recently refreshed on November 18th 2021. The study needs 60 participants from a single site."
Answered by AI
Could you provide details of any other investigations that have been conducted utilizing Intravenous digoxin?
"Currently, there are 9 clinical trials studying intravenous digoxin with two of those in their Phase 3 stages. The primary trial is based out Nedlands, Western Australia yet the treatment can be found at a total of 85 medical locations across the country."
Answered by AI
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