Clinical Trials

The purpose of this study is to evaluate an ultrasound technology that may be used to evaluate liver fibrosis.

The purpose of this study is to report the proportion of thiamine deficiency (as defined by the Mayo Clinic Laboratory reference range) in liver transplant patients.

The primary aim of this study is to use an MRI-based Muscle Assessment Score (MAsS), which includes both muscle volume and fat infiltration, at the transplant candidacy evaluation and other follow-up MRI examinations as clinically indicated, as an objective, standardized, and quantitative measure of muscle health and explore the link between muscle composition and adverse outcomes and mortality. In addition, there are growing numbers of high-risk donor livers, such as presenting with steatosis or exposed to prolonged ischemia time.

A secondary aim is to gather information on the association between transplant recipient muscle composition and donor liver characteristics ...

Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.

Will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life?

The purpose of this study is to compare the accuracy of non-invasive MRE (Magnetic Resonance Elastography) with the results of liver biopsy and/or MRI (Magnetic Resonance Imaging).

The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program

The purpose of this study is to improve international patient's understanding of the primary diagnosis and recommended treatment program, by reducing social, cultural and religious barriers that may hinder in our nursing education

 The purpose of this study is to implement a free-breathing hepatic MRE technique capable of being performed in as little as 0.8 seconds per slice which could significantly reduce the breath-hold requirements for typical MRE exams, establish a rapid imaging protocol, and improve clinical patient throughput.

The purpose of this study is to develop stem cells from cells within patients’ skin. Stem cells are a unique type of cell capable of converting into multiple other adult cell types. The stem cells will later be converted to liver cells and used to better understand liver disease and help develop treatments.

This Pilot study will enable development & assessment of a Polycystic Liver Disease-specific patient reported outcomes questionnaire (PLD-Q). Polycystic liver disease (PLD) is characterized by the formation of numerous cysts in the liver, and can lead to severe symptomatic hepatomegaly. It is common in patients with autosomal dominant polycystic liver disease (ADPLD) and autosomal dominant polycystic kidney disease (ADPKD).

The primary purpose of this study is to develop an understanding of the prevalence, characteristics, and outcomes of major bleeding and clinically relevant non-maor bleeding in hospitalized patients with cirrhosis undergoing invasive procedures.

This study is being done to collect and store samples of blood from patients with liver disease for a research study to be able to find a new and better way to detect liver cancer.

The purpose of this study is to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects.

Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

The purpose of this trial is to evaluate the effectiveness and safety of 2 treatment regimens of CAM2029 versus placebo in patients with Polycystic Liver Disease (PLD). 

The purpose of this study is to evaluate the diagnostic performance of Endoscopic Ultrasound (EUS) shear wave elastography in the assessment of liver fibrosis compared to magnetic resonance (MR) elastography.

The purpose of this study is to compare the incidence and frequency of elevated liver enzymes or parenteral (IV) nutrition-associated liver disease, in adult patients who are receiving daily versus three time per week soybean based intravenus (IV) fat emulsions.

Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

This research study will help us to improve our understanding of normal liver and gallbladder function. Additionally, this research study will be used to try to discover new therapies for treating liver disease using gallbladder cells.

This study is being done to better understand the relationship between inflammation in your AT, abnormal deposition of fat around your liver and how this affects its appearance and function and ultimately insulin resistance.

The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing in established patients with liver disease seen in the Division of Gastroenterology/Hepatology, in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of medications.

The purpose of this study is to assess the repeatability and reproducibility of a set of specified MRI quantitative biomarkers.  The imaging biomarkers will cover an array of methods that could be applicable to non-alcoholic fatty liver disease (NAFLD), including liver fat, liver stiffness, corrected T1 relaxation time and body composition assessments. The data collected will be used to inform a decision of which of these biomarkers has sufficient precision to be advanced to NIMBLE Stage 2.

NIMBLE is a comprehensive, five-year collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic ...

The purpose of this study is designed to evaluate the effectiveness and safety of intravenous Lucassin® (terlipressin) versus a placebo for the treatment of type 1 hepatorenal syndrome in patients receiving standard of care albumin therapy.

The purpose of this study is to determine if extracellular (EV) counts and content can differentiate Alcoholic Hepatitis (AH) from alcoholic liver disease as well as end stage liver disease due to other causes.

The study plans to follow three groups of cirrhotic patients from the time of hospital dismissal randomly divided into either receiving standard of care, using devices through which they can communicate with the clinical teams and using devices and structured follow-up over thirty days. The study aims to develop these devices so as to learn quickly about issues that patients and their caregivers are facing so that clinicans can intervene to stop unnecessary re-hospitalizations in this population.

The purpose of this study is to observe participants with hemophilia A and B who have and have not undergone liver transplantation. Participants will be asked to complete health related quality of life questionnaires and provide medical history.

This is an Open Label, Multicenter, pilot clinical trial to assess the efficacy and safety of an oral selective Endothelin Receptor Antagonist (ambrisentan) in patients with portopulmonary hypertension.

Preliminary evidence suggests that ambrisentan is safe and effective in patients with portopulmonary hypertension. The goal of therapy for these patients is to improve symptoms of dyspnea and to improve pulmonary hemodynamics to a mean pulmonary artery pressure <35 mm Hg in order to make patients eligible for liver transplantation. Therefore, the primary endpoints for this study will include 6 minute walk distance (6MWD) and pulmonary vascular resistance (PVR).

Eligible subjects ...

About this study

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world and a major public health issue in the US. It is estimated to affect 1 in 4 adults and it is most commonly found in people who are overweight or obese. Because it is a silent disease (without symptoms until end stage) and the lab tests can be normal, it can be missed in early stages. The fat in the liver can lead to inflammation and eventually scar deposition, which can progress to cirrhosis, liver cancer and ...

This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices.

The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests

The purpose of this study is to compare the frequency of occurance of kidney stone formation in liver disease patients compared to the general population.

The purpose of this study is to identify clinical parameters that may help to predict clinical outcomes prior to the evolution of the admitting diagnosis for cirrhosis, a very important clinical observation for the long-term. We are not participating in optional blood collection. 

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

The primary purpose of this study is to collect and analze data evaluating the effectiveness of the alfapump to control ascites as determined by the reduction in the need for repeated paracentesis compared to baseline

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFLD or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients with NAFLD or NASH within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular ...

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of GS-9674 in adults who have primary sclerosing cholangitis.

This research study is being done to create a collection of biospecimens (blood, urine, cyst fluid, bile, kidney or liver tissue, etc.) that can be used to facilitate the conduction of research on polycystic kidney and/or liver disease.

The primary objectives of this study are to evaluate the safety and effectiveness of obeticholic acid treatment compared to placebo on both tissue structure improvement and liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis, marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However, milder forms of alcoholic hepatitis often do not cause any symptoms. Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months, sometimes without permanent sequelae but often with residual ...

The purpose of this study is to examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period on the clinical course and progression of primary sclerosing cholangitis.

The purpose of this study is to to assess the effects of different Oral Vancomycin (OV) doses on the clinical and biochemical course in adult patients with Primary Sclerosing Cholangitis (PSC).

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis.

The purpose of this study is to demonstrate the safety and effectiveness of BMS-986036.in participants with NASH and stage 3 liver fibrosis.

The first double-blind 72-week treatment period will assess the efficacy and safety of elafibranor on the resolution of NASH without worsening of fibrosis at the intermediate efficacy analysis, followed by a Long-term Treatment Period to assess efficacy on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (all-cause mortality, progression to histological cirrhosis, and the full list of portal hypertension/cirrhosis related events).

The purpose of this study is to investigate the effectiveness of ultrasound imaging for staging liver steatosis, using liver fat content measured by MRI as the reference standard.

The purpose of this research is to create a registry of patients having or at risk for metabolic liver disease for investigations into the molecular pathogenesis of cirrhosis, liver cancer, and end-stage liver disease.

The purpose of this study is to evaluate the usefulness of combining a core liver biopsy guided by endoscopic ultrasound and stomach balloon placement by endoscope for the diagnosis and treatment of fatty liver disease and obesity.

The purpose of this study is to evaluate the effectiveness and safety of three treatment doses of CC-90001 (100 mg, 200 mg and 400 mg PO QD), compared with placebo, in NASH subjects with Stage 3 and Stage 4 fibrosis. This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

The purpose of this study is to create a clinical database and bio-repository by obtaining blood, urine, and stool samples (e.g., biological samples) and personal health information from patients to use in future research studies related to alcoholic hepatitis or other diseases.

This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).

The purpose of this study is to evaluate the safety and effectiveness of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

The purpose of this study is to investigate the potential effectiveness of dupilumab in the treatment of moderate-to-severe, chronic hepatic pruritus.

The purpose of this study is to determine the impact of foam sclerotherapy of large, dominant kidney/liver cysts on quality of life outcomes and kidney/liver cyst volumes at up to 12 months of follow-up in patients with autosomal dominant polycystic kidney disease (ADPKD) and autosomal dominant polycystic liver disease (ADPLD).
 

The purpose of this study is to determine if there are differences in the metabolites (enzymes and other proteins) found in portal venous blood (blood in the portal vein, which delivers blood from the intestines to the liver), peripheral venous blood, and bile between individuals with liver disease undergoing liver transplantation and healthy donors. With this information, we may be able to better understand the importance and nature of the relationship between the gut (i.e. intestines) and the liver in the context of liver disease and identify pathways which may lead to the development of new and improved therapies for ...

The purpose of this study is to assess a new drug to decrease liver fat in subjects with Non-Alcoholic Steatohepatitis or Non-Alcoholic Fatty Liver Disease.

The purpose of this study is to evaluate the safety and effectiveness of BMS-986036 in adults with nonalcoholic steatophepatitis (NASH) and compensated liver cirrhosis.

The purpose of this study is to facilitate discovery and development of novel biomarkers of risk and early detection, etiologic factors relating to liver disease, and novel targeted therapeutic and chemopreventive strategies for liver disease such as PSC, PBC, PLD, NAFLD, NASH, ASH, HCC, donors (non-diseased and diseased) for liver transplant or non-liver diseased subjects scheduled for surgery will serve as controls.

The primary aim of this study is to define a comprehensive digital phenotype that predicts risk for near-future relapse or relapse in alcohol use in patients with alcohol-associated liver disease.

The secondary aim of this study is to assess the relationship between this digital phenotype and markers of disease severity outcome, including MELD score and readmission rates.

The primary objective of this study is to evaluate whether the combination of semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR) causes fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with compensated cirrhosis due to NASH.

This study is to evaluate the safety and efficacy of simtuzumab (GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases:

• Randomized Double-Blind Phase
• Open Label Phase (optional)

A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information ...

The purpose of this study is toexamine whether increased sphingosine 1 phosphate : ceramide ratio and circulating bile acids are associated with HPS in patients with advanced liver disease.

The purpose of this study is to investigate the effectiveness and safety of three dose levels of subcutaneous semaglutide for the treatment of patients who have fatty-liver disease not caused by alcoholism.

The purpose of this study is to assess the pharmacodynamics (PD) of HM15211 after administration of multiple subcutaneous (SC) doses compared to placebo on the liver by proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH Clinical Research Network (CRN) fibrosis score.

Resolution of NASH is defined as non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of 0–1 for inflammation, 0 for ballooning, and any other value for steatosis

This study will evaluate whether simtuzumab (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with non-alcoholic steatohepatitis (NASH). It will consist of 2 phases: - Randomized Double-Blind Phase - Open Label Phase (optional)

The purpose of this study is to identify risk factors and potential predictors for NAFLD and NASH recurrence after liver transplantation.

We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.  

The purpose of this study is to identify the clinical characteristics, the management and the outcomes of acute kidney injury (AKI) in patients with cirrhosis worldwide. Additionally, to establish the severity of AKI across different regions, to identify precipitants of AKI across different centers, to identify the phenotypes of AKI across different centers, to evaluate differences in the management of AKI across different centers and their impact on clinical outcomes, and to assess outcomes of acute kidney injury (resolution of AKI, in-hospital mortality, 28-day mortality, 90-day mortality).

This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC).

The purpose of this study is to evaluate the safety of acamprosate in individuals with alcohol-use disorder (AUD) and alcohol-related liver disease.

The purpose of this study is to evaluate the effectiveness of 2 mg/kg and 4 mg/kg lean body mass (LBM) of belapectin (GR-MD-02) compared to placebo in preventing the development of esophageal varices.

The purpose of this study is to define the prevalence and impact of cognitive impairment and their impact on HRQOL in elderly patients with cirrhosis compared to elderly patients without cirrhosis.

This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will be treated with either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Subjects on GSK2330672 will also receive placebo tablets to maintain blinding. The total duration of a subject's participation will be up to 45 days of screening and 24 weeks of study including follow-up.

The purpose of this study is to determine if vasodilators for the lungs can decrease liver stiffness, shown by Magnetic resonance elastography (MRE).  The study also aims to identify any clinical, laboratory, echocardiographic, imaging, and hemodynamic parameters that connect with improved outcomes of cardiac and liver status after starting the pulmonary vasodilators.

The purose of this study is to assess the effectiveness, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

The overall objective of this proposal is to conduct a systematic approach to dissect both genetic underpinnings and non-genetic factors in the development of adult autoimmune liver diseases including autoimmune hepatitis (AIH), overlap AIH with Primary Biliary Cirrhosis (AIH-PBC), overlap AIH with Primary Sclerosing Cholangitis (AIH-PSC), and drug-induced autoimmune-like hepatitis (DIAIH).

The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes ...

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.

The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.

GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.

The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.

Falls are common and catastrophic in cancer patients. Cancer patients are vulnerable to falls due to muscle loss. In prescribing exercise in a data driven manner to cancer patients, our hypothesis is this "prescription" for exercise will eventually be demonstrated to reduce the occurrence of injurious falls.