Intravenous digoxin for Hepatitis, Toxic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Yale New Haven Hospital, Yale School of Medicine, New Haven, CT
Hepatitis, Toxic+7 More
Intravenous digoxin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether digoxin is safe and effective in patients with severe acute alcohol associated hepatitis.

See full description

Eligible Conditions

  • Hepatitis, Toxic
  • Acute Alcoholic Hepatitis
  • Steatohepatitis Caused by Ingestible Alcohol
  • Alcohol-Induced Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Intravenous digoxin will improve 1 primary outcome, 5 secondary outcomes, and 10 other outcomes in patients with Hepatitis, Toxic. Measurement will happen over the course of Up to 28 days.

15 months
Ability to recruit 4 patients a month.
Up to 28 days
Development of ECG abnormalities
Development of new or recurrent renal failure.
Feasibility of digoxin dose adjustments in renal insufficiency.
Feasibility of digoxin dosing in a timely manner.
Organ Dysfunction (Multi-Organ) with Sequential Organ Failure Assessment (SOFA)
Organ Dysfunction (Multi-Organ) with the Multi-Organ Dysfunction Score (MODS)
Organ dysfunction (Liver - Lille Score)
Organ dysfunction (Liver Enzyme: Alanine Aminotransferase [ALT])
Organ dysfunction (Liver Enzyme: Alkaline Phosphatase [ALP])
Organ dysfunction (Liver Enzyme: Aspartate Aminotransferase [AST])
Organ dysfunction (Liver Enzyme: Bilirubin)
Organ dysfunction (Liver) with Model for End-stage Liver Disease (MELD)
Practicality of daily digoxin measurements
Up to 90 days
Mortality at 7, 14, 28, 90 days
Racial and ethnic diversity in subject recruitment and retention.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm B: No Digoxin
1 of 2
Arm A: Digoxin
1 of 2
Active Control
Experimental Treatment

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Intravenous Digoxin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm A: Digoxin
Drug
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 B: No DigoxinIn the no digoxin arm, no study drug or placebo will be administered.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 15 months for reporting.

Who is running the study

Principal Investigator
B. B.
Prof. Bubu Banini,, MD PhD
Yale University

Closest Location

Yale New Haven Hospital, Yale School of Medicine - New Haven, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
was present in all the livers of the alcoholics studied show original
Age between 21 and 65 years, including 21 and 65 years. show original
of hepatitis in a person with a history of habitual heavy drinking Based on a person's history of heavy drinking, alcohol-associated hepatitis can be diagnosed clinically through symptoms or through histologic evidence of hepatitis. show original
The person has had jaundice for more than 8 weeks. show original
The patient's MDF is 32 to 60 or their MELD is 20 to 30 on Day 0 of the trial. show original
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 is greater than 1.5 and both values are less than 400 IU/l. show original
I'm starting steroid treatment for my acute alcohol-associated hepatitis. show original

Patient Q&A Section

How many people get hepatitis a year in the United States?

"About 8.2% of American adults ages 19 and up are infected with viral hepatitis or chronic liver diseases every year. The prevalence of hepatitis A is 1.3% while 0.8% are infected with hepatitis B. The prevalence of hepatitis C infecting people 20 years or older has been estimated around 2.3%, while 0.7% are estimated to be infected with hepatitis D. Hepatitis E is estimated around 1 per 2,500 people. In 2000 about 1.8% of American adults were infected with chronic liver disease." - Anonymous Online Contributor

Unverified Answer

What is hepatitis?

"Hepatitis, a common liver condition in humans, is a viral disease in which it damage to the liver. Because hepatitis is a general disease, the exact cause of all types of it not yet known, while some viruses are known to cause disease, there are still many types of hepatitis for which it not yet known what causes it, so many types of hepatitis. There is a wide variety of hepatitis from the most common to the rarest. Hepatitis B (HBV) and Hepatitis C (HCV) are the most dangerous, known causes of liver disease due to hepatitis in humans." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hepatitis?

"Most treatments for chronic liver diseases are symptomatic. The diagnosis and/or treatment of HBV and HCV, are usually prescribed by a physician, in most countries." - Anonymous Online Contributor

Unverified Answer

Can hepatitis be cured?

"Hepatitis C can be cured, provided medical treatment is successful. In the absence of cirrhosis, HBeAg seroconversion occurs in 60% of HBeAg-negative cases in 9 to 12 months. Cirrhosis requires a higher seroconversion rate of over 60%. The likelihood of cure drops dramatically with increased grades of fibrosis." - Anonymous Online Contributor

Unverified Answer

What causes hepatitis?

"A diverse range of environmental exposures, medical and psychiatric, may trigger hepatitis. Hepatocellular carcinoma may occur in many types of liver disease. Prevention of hepatitis is based on vaccination and safe drinking water use, and, for individuals at risk, timely diagnosis and appropriate treatment." - Anonymous Online Contributor

Unverified Answer

What are the signs of hepatitis?

"Signs of hepatitis will not be experienced by any person, because patients typically lack the clinical symptoms. The signs of hepatitis are those that are associated with liver damage, and include itchiness, jaundice, and fever. The main features of patients with severe hepatitis include rapid deterioration of liver function and liver transplantation or liver failure. The severity of symptoms can be influenced by the immune status of the individual. In the UK, most patients with hepatitis die within the first week of their infection. Therefore, when testing a person for hepatitis, it is not useful to rely on clinical suspicion alone. It is also important to do some sort of lab test." - Anonymous Online Contributor

Unverified Answer

Does intravenous digoxin improve quality of life for those with hepatitis?

"For patients with chronic heart failure and significant chronic liver disease, intravenous digoxin appears to reduce morbidity and mortality. This benefit is not obtained by treating patients with oral digoxin after they become digoxigenously st uped." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hepatitis?

"Most adult cases of hepatitis B (72%) and hepatitis A (67%) occurred between the ages of 18 and 24 years (range, 16-55 years). Most cases of hepatitis B tended to occur younger than age 30 years (range, 20-34 years), because of [early childbearing and promiscuous behaviors of males of certain age range] as well as the greater prevalence of HB infection in young adults in Guangxi Province. However, all children with HBV infection need to get tested periodically regardless of their ages, because even young infants are in danger of infection. The prevalence of HBV infection in children younger than 15 years is increasing." - Anonymous Online Contributor

Unverified Answer

Has intravenous digoxin proven to be more effective than a placebo?

"Use of iv digoxin is safe and effective for the treatment of heart failure owing to heart failure or atrial fibrillation, and was better than any placebo (P<0.0001). Digoxin may be used as a therapy in patients receiving an implantable cardioverter-defibrillator." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hepatitis?

"There are multiple hepatitis research activities at OUPHMS, including clinical trials and meta-analyses, and you can check out the latest news from OUPHMS’ web site. The website provides information detailing where to find recent articles in Hepatitis and links to relevant clinical trials. For example, there is an overview of the latest research on hepatitis C." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving intravenous digoxin?

"Clinical trials are not reported on in this journal. However, it seems likely that this would meet the Journal's usual inclusion criteria given the wide range of intravenous digoxin formulations used in clinical practice to treat heart diseases as well as its use under routine clinical conditions." - Anonymous Online Contributor

Unverified Answer

Is intravenous digoxin safe for people?

"The recommended dose of one i.v. dose of digoxin 0.125 mg/kg does not result in either serious or nonfatal adverse event in children who have normal left ventricular function, but with moderate to severe pulmonary disease. No deaths have occurred in these children who received digoxin. Because of the safety profile, digoxin can be given by i.v. route in patients with moderate to severe pulmonary disease but with a normal left ventricular function." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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