Clinical Trials for Alcoholic hepatitis

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Alcoholic hepatitis from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 18
• Active, not recruiting: 6
• Completed: 14
• Other: 12

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT03025074 — Blood Collection Biorepository for Liver Disease Research

The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

NCT04088370 — Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis

Inflammatory responses in response to alcohol have been identified as contributing to the development of alcoholic hepatitis. The inflammatory response including that to LippoPolySaccharide is known to lead to progression of alcoholic liver disease. In addition to the inflammatory response mitochondrial perturbations exist and redox homeostasis is altered in patients with alcoholic hepatitis. T…

NCT04106518 — Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease

Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their ou…

NCT04525833 — Liver Disease and Other Systemic Diseases

Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.

NCT03845205 — Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH

Given the severe consequences of alcohol relapse following liver transplantation for alcoholic hepatitis (AH-LT), it is critical to accurately identify alcohol use and implement alcohol interventions early in the post-transplant period to optimize patient outcomes. The proposed randomized clinical trial will examine the implementation and effects of integrated, person- and computer-delivered al…

NCT04690972 — “Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases”.

Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies.

NCT05018481 — HA35 Moderate Alcoholic Hepatitis (AH) Study

Eligible participants will be asked to take a placebo/treatment capsule for 90 days and participate in two in-person study visits, one at the start of the 90 days and the second at the completion of study supplement administration. Both visits will include a physical exam, clinical labs, body composition measurements, muscle strength tests, questionnaires, and urine and stool collections. Addit…

NCT05294744 — Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)

This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.

NCT06152250 — Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis

Non-alcoholic fatty liver disease (NAFLD) is a nosological entity that groups together non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). Unlike NAFL, NASH is characterized by intrahepatic inflammation, and is solely at risk of progression to cirrhosis and hepatocellular carcinoma (HCC).

It is currently estimated that NAFLD affects approximately 25% of the world’s adult…

NCT06159244 — Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients

In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alc…

NCT05832229 — Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States

This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.

NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome

In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.

NCT07262515 — Integrative Epidemiology of Prognosis in Patients With Acute Alcoholic Hepatitis at AP-HP

Acute alcoholic hepatitis (AAH) is a severe liver disease that often occurs in individuals with prolonged excessive alcohol consumption. Patients face a high risk of liver failure, complications, and death, despite available treatments. Current prognostic scores based on blood tests provide limited accuracy and do not capture the full complexity of the disease.

The purpose of this study is to …

NCT06307964 — Intra-Hepatic Microbiota in Alcoholic Hepatitis

Alcoholic hepatitis (AH) is a serious complication of alcoholic liver disease (ALD). The histological presentation of AH is characterized by neutrophilic lobular inflammation, macrovesicular steatosis, hepatocyte ballooning and necrosis and the presence of Mallory bodies. In cases of severe HA, defined by a modified Maddrey score of 32 or above, mortality at 1 month is estimated at between 10 a…

NCT07060547 — Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease

This is a study to measure liver recovery in patients with recent alcohol-associated liver injury by assessing liver function and physiology using HepQuant DuO. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and 2 blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data to better monitor and treat patients w…

NCT07428538 — Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)

The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.

NCT06956482 — PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

Only patients suffering from a severe form of alcoholic hepatitis (Maddrey’s discriminant function greater than 32) require medical treatment. Oral prednisolone for 28 days is the only treatment which has been proven to improve short-term survival over placebo in patients with severe alcoholic hepatitis. However, prednisolone alone cannot be regarded as an ideal treatment because some patients …

NCT06843148 — Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.

Metabolic dysfunction-associated steatotic liver disease (MASLD) (aka non-alcoholic fatty liver disease), commonly occurring in individuals with obesity and type 2 diabetes can lead to liver inflammation/ fibrosis. MASLD results from fat being disproportionately deposited in the liver.

The goal of this mechanistic study is to investigate metabolic response in patients aged 20 to 80 years with …

Active, Not Recruiting

NCT01047735 — The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes

This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients.

T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney …

NCT02473341 — Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis

Severe alcohol-associated hepatitis is associated with hepatocellular necrosis, inflammation, hyperactivated immune system, paradoxical immune exhaustion, leaky gut, and alteration in the gut microbiome. The leading cause of mortality is a bacterial infection with multi-organ failure.

Pentoxifylline was ineffective and Interleukin-1-based therapies - Anakinra and Canakinumab have not improved …

NCT05147090 — Effects of Empagliflozin on Fibrosis and Cirrhosis in Chronic Hepatitis B Patients

Chronic hepatitis B (CHB) affects 257million individuals worldwide. In 2017, it caused around 39.7 million cases of cirrhosis and 0.4 million cirrhosis-related deaths in 2017. However, there is no specific treatment for liver fibrosis/cirrhosis. Although nucleos(t)ide analogues (NAs) profoundly suppress viral replication, fibrosis/cirrhosis progression can still occur in NA-treated patients.

S…

NCT05740358 — Liver Cirrhosis Network Cohort Study

Liver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months (180 days), with opportunities to complete specific visit c…

NCT07502755 — Non-invasive Tests for Non-alcoholic Steato-hepatitis

The main objective is to study and validate a new approach for NASH and liver fibrosis diagnosis and personalized follow-up based on monocyte biomarkers and plasma metabolites. The investigators will assess if PLIN2 and RAB14 can be used not only to identify subjects with NASH and advanced fibrosis but also for monitoring the effect of treatment alone or in combination with other metabolic para…

NCT06842563 — Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial

This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection. The test results are compared against clinical reference standards, including pathological and/or imaging diagnoses, to assess the product’s diagnostic performance. Additionally, for each gene detectable …

Not Yet Recruiting

NCT06890039 — A-TANGO Phase 2 Study

The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe.

Description of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed ci…

NCT07176741 — LiverTREM-1: Hepatic TREM-1 Expression and Prognosis in Severe Alcoholic Hepatitis

Background & Rationale Severe alcohol-related hepatitis (SAH) is a serious condition with a 3-month mortality rate of ~30%. Diagnosis and prognosis are complex due to non-specific and insensitive clinical, biological, and histological indicators. Corticosteroids-the only validated treatment-are only effective in 50% of cases and can worsen outcomes in non-responders by promoting infections. L…

NCT07644936 — Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach

This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS “S. de Bellis”. Blood samples will …

NCT07631637 — Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH.

In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring. The study will compare ALN-CIDEB with placebo to understand how well ALN-CIDEB works to lower the amount of fat in the liver.

The study is looki…

NCT07465588 — Financial Rewards for Reducing Alcohol Use in Patients With Liver Disease

This study tests whether providing financial rewards based on a blood test result can help people with alcohol-associated liver disease (ALD) stop or reduce their drinking. The blood test is called phosphatidylethanol (PEth), which can detect alcohol use over the past three to four weeks. The financial reward program is called contingency management (CM).

The study has two parts. Part 1 involv…

NCT07133854 — How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver

Steatotic liver disease associated with metabolic dysfunction (MASLD) is a disease caused by excess fat storage in the liver. Excessive fat delivery to the liver and MASLD typically occurs in people with abdominal obesity and type 2 diabetes. Type 1 diabetes (T1D) is also associated with a marked increase in the release of fat from adipose tissues and MASLD is increased in T1D and significantly…

Enrolling by Invitation

NCT04234139 — Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation

The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public’s opinion regarding this practice.

Completed Trials

NCT00116454 — Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis

The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurre…

NCT01756794 — Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment

The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medica…

NCT01903798 — A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis

This clinical trial will test two new therapies for the treatment of alcoholic hepatitis. Patients who “respond” to the current standard of care therapy for alcoholic hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly assigned to either continue on standard therapy, or, to begin treatment with rilonacept in combination with standard therapy. Patients who a…

NCT02281929 — Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone

Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for 28 days. However, about 25-35% of patients do not take benefit from this treatment and die within the 6 months following the diagnosis. Numerous trials have evaluated the impact of several strategies in association with corticosteroids. None of them has shown an improvement in survival (primary endpoint)…

NCT02344680 — Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

A cohort of adults with HIV-HBV co-infection will be created in Lusaka, Zambia, to describe the short and long-term (up to 10 years of follow-up) HBV and liver outcomes, including the effectiveness of current therapies, and to identify the risk factors for major endpoints of interest, including HCC and HBV functional cure. This cohort will also create a pool of potential participants for in-dep…

NCT03158818 — Chronic Hepatitis B Virus Infection in Zambia

Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical feature…

NCT03743272 — Repeatability and Reproducibility of Multiparametric MRI

This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS, Perspectum Diagnostics, Oxford, UK) protocol across different field strengths, scanner manufacturers and models.

NCT03149627 — Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults

The purpose of this study is to recruit a random and representative sample of individuals within several Zambian communities for markers of Hepatitis B Virus (HBV) and to characterize chronic HBV infection and indications for treatment.

NCT04555434 — Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH

A study for evaluating the improvement effect on Metabolic dysfunction-associated steatotic liver disease (MASLD) of probiotics

Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with dysbiosis of the gut microbiota and altered host metabolic homeostasis. Probiotics have been proposed as a potential therapeutic strategy to modulate gut microbial composition and impr…

NCT05594953 — Outcomes Using MARS for Patients With ALF

Retrospective chart review will be conducted on patients at Methodist Dallas Medical Center, meeting the inclusion criteria from January 1, 2019 to December 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures.

NCT05669677 — Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease

Background:

The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especially those with an advanced condition called cirrhosis, do not respond to many vaccines as well as …

NCT06285253 — miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial

The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) …

NCT06685692 — A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)

A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)

NCT07622680 — Comparative Effects of Mediterranean and DASH Diet on Hepatic Function

Participants were assigned into three groups Control group recieving general dietary guidelines, Mediterranean diet intervention group DASH dietary intervention group

Other (Suspended)

NCT04306939 — Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study

This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making.

The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, i…

Other (Terminated)

NCT03534141 — Mild Hypothermia and Acute Kidney Injury in Liver Transplantation

Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the pa…

NCT05014087 — Digoxin In Treatment of Alcohol Associated Hepatitis

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 random…

NCT05282121 — A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)

This study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or nonalcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the liver).

The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) taken alone or in combination with a medicine called empagliflozin h…

NCT05639543 — FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study

The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).