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Digoxin In Treatment of Alcohol Associated Hepatitis (DIGIT-AlcHep)

Primary Purpose

Acute Alcoholic Hepatitis, Chemical and Drug Induced Liver Injury, Alcohol-Induced Disorders

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravenous digoxin
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Alcoholic Hepatitis focused on measuring Acute alcoholic hepatitis, Liver injury, Liver inflammation, Liver disease, Digoxin

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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:

    • Antiarrthymics (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

Sites / Locations

  • Yale New Haven Hospital, Yale School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A: Digoxin

Arm B: No Digoxin

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Ability to recruit 4 patients a month.
The number of subjects recruited per month will be summarized to assess the study's primary recruitment feasibility objective.

Secondary Outcome Measures

Practicality of daily digoxin measurements
90% of patients have digoxin checked levels within the pre-specified time window
Feasibility of digoxin dosing in a timely manner.
90% of patients receive every scheduled dose of the drug
Feasibility of digoxin dose adjustments in renal insufficiency.
90% of necessary dose adjustments were made appropriately in response to digoxin levels
Mortality at 7, 14, 28, 90 days
The mortality rates at different time points in the digoxin group and in the control group
Development of ECG abnormalities
The number and proportion of patients in the digoxin and control groups with ECG changes compared to baseline

Full Information

First Posted
July 20, 2021
Last Updated
April 19, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT05014087
Brief Title
Digoxin In Treatment of Alcohol Associated Hepatitis
Acronym
DIGIT-AlcHep
Official Title
Digoxin In Treatment of Alcohol Associated Hepatitis (DIGIT-AlcHep)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, single center, open label, randomized controlled trial to determine the feasibility of conducting a future study with respect to patient recruitment, 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 study of digoxin versus no digoxin in patients with severe alcohol associated hepatitis is to assess the feasibility of conducting a large randomized trial to detect efficacy with respect to patient recruitment, digoxin administration and dose adjustment in patients hospitalized with severe alcohol associated hepatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single center, open label, randomized 1:1 controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Digoxin
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B: No Digoxin
Arm Type
No Intervention
Arm Description
In the no digoxin arm, no study drug or placebo will be administered.
Intervention Type
Drug
Intervention Name(s)
Intravenous digoxin
Other Intervention Name(s)
Lanoxin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability to recruit 4 patients a month.
Description
The number of subjects recruited per month will be summarized to assess the study's primary recruitment feasibility objective.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Practicality of daily digoxin measurements
Description
90% of patients have digoxin checked levels within the pre-specified time window
Time Frame
Up to 28 days
Title
Feasibility of digoxin dosing in a timely manner.
Description
90% of patients receive every scheduled dose of the drug
Time Frame
Up to 28 days
Title
Feasibility of digoxin dose adjustments in renal insufficiency.
Description
90% of necessary dose adjustments were made appropriately in response to digoxin levels
Time Frame
Up to 28 days
Title
Mortality at 7, 14, 28, 90 days
Description
The mortality rates at different time points in the digoxin group and in the control group
Time Frame
Up to 90 days
Title
Development of ECG abnormalities
Description
The number and proportion of patients in the digoxin and control groups with ECG changes compared to baseline
Time Frame
Up to 28 days
Other Pre-specified Outcome Measures:
Title
Organ dysfunction (Liver - Lille Score)
Description
Changes in liver-related function will be determined through assessment of Lille score. The model is based on: Age, Albumin, Bilirubin (initial), Bilirubin (day 7), Creatinine, PT. Survival probability at 6 months is defined by a cutoff of 0.45: 6-month survival probability of patients with a Lille model above 0.45 is about 25% contrary to patients with a Lille model below this cutoff (85% survival).
Time Frame
Up to 28 days
Title
Organ dysfunction (Liver) with Model for End-stage Liver Disease (MELD)
Description
Changes in liver-related function will be determined through assessment of Model for End-stage Liver Disease (MELD) score, a number that ranges from 6 (least sick) to 40 (most sick) based on blood tests. The lab tests used to determine the MELD score are creatinine, bilirubin, sodium and international normalized ratio (INR).
Time Frame
Up to 28 days
Title
Organ dysfunction (Liver Enzyme: Bilirubin)
Description
Changes in liver-related function will be determined through assessment of the liver enzyme bilirubin
Time Frame
Up to 28 days
Title
Organ dysfunction (Liver Enzyme: Alkaline Phosphatase [ALP])
Description
Changes in liver-related function will be determined through assessment of liver enzymes (alkaline phosphatase [ALP])
Time Frame
Up to 28 days
Title
Organ dysfunction (Liver Enzyme: Aspartate Aminotransferase [AST])
Description
Changes in liver-related function will be determined through assessment of liver enzymes (aspartate aminotransferase [AST])
Time Frame
Up to 28 days
Title
Organ dysfunction (Liver Enzyme: Alanine Aminotransferase [ALT])
Description
Changes in liver-related function will be determined through assessment of liver enzymes (alanine aminotransferase [ALT])
Time Frame
Up to 28 days
Title
Organ Dysfunction (Multi-Organ) with Sequential Organ Failure Assessment (SOFA)
Description
Dysfunction in other organs will be assessed using Sequential Organ Failure Assessment (SOFA) score which is calculated based on a person's liver function, kidney function, nervous system, coagulation, circulation, and respiratory status. The score ranges from 0 (least sick) to 24 (most sick).
Time Frame
Up to 28 days
Title
Organ Dysfunction (Multi-Organ) with the Multi-Organ Dysfunction Score (MODS)
Description
Dysfunction in other organs will be assessed using Multi-organ dysfunction score (MODS), calculated based on a person's liver function, kidney function, nervous system, coagulation, circulation, and respiratory status. The score ranges from 0 (least sick) to 24 (most sick).
Time Frame
Up to 28 days
Title
Development of new or recurrent renal failure.
Description
Creatinine rise ≥ 0.5 mg/dL or ≥ 20% from baseline or requiring renal replacement therapy.
Time Frame
Up to 28 days
Title
Racial and ethnic diversity in subject recruitment and retention.
Description
Race and ethnicity of enrolled subjects and subjects who completed the study will be summarized using count and proportion to assess the study's objective of enrolling and retaining at least 10% Black and at least 10% Hispanic participants to study completion (90-days follow-up)follow-up.
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bubu Banini, MD, PhD
Phone
203-737-6063
Email
bubu.banini@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime Oriol
Phone
203-785-6497
Email
maxime.oriol@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bubu Banini, MD, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital, Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bubu Banini, MD, PhD
Phone
203-737-6063
Email
bubu.banini@yale.edu
First Name & Middle Initial & Last Name & Degree
Bubu Banini, MD, PhD
First Name & Middle Initial & Last Name & Degree
Wajahat Mehal, MD PhD
First Name & Middle Initial & Last Name & Degree
Simona Jakab, MD
First Name & Middle Initial & Last Name & Degree
Brooke Rice, MD

12. IPD Sharing Statement

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Digoxin In Treatment of Alcohol Associated Hepatitis

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