Clinical Trials

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.

The purpose of this study is to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient. Both drugs are FDA-approved. Mavyret™ is currently used commercially to treat Hepatitis C and Zetia® is used commercially to treat high cholesterol.

The purpose of this study is to evaluate the safety and effectiveness of the VitaSmart Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using static cold storage (SCS) followed by hypothermic oxygenated machine perfusion (HOPE) versus SCS only.

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 utilize liver allografts from HCV seropositive donors into 10 HCV seronegative recipients. 

The purpose of this study is evaluation of tumoral markers at the time of transplant to assess recurrence risk, and assessment of tumor sensitivity to a panel of candidate therapeutics as a guide to adjunct or therapeutic therapies for recurrent hepatocellular cancers (HCC).  

The purpose of this study is to examine the changes in the gut microbiome of patients before and after liver transplantation, including the donor organ microbiome changes to understand how these changes are related to organ rejection, recurrent disease or infection post transplant.

The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had a liver transplant. Researchers will examine blood, urine, and tissue samples and try to identify markers for certain conditions such as rejection, response to therapy, and scarring of the liver. Additionally, researchers would like to identify biomarkers that can detect damage to the native kidneys before blood levels of creatinine rises. By studying gene expression, researchers hope to be able to diagnose these conditions earlier and improve liver survival.

The purpose of this study is to test the tolerability, safety, and effectiveness of 12 weeks once-daily fenofibrate in reducing Ischemic Cholangiopathy (IC) incidence after Donation after Circulatory Death (DCD) liver transplantation. Additionally to assess the association between serum markers of cholestasis and development of IC. Tolerability and safety will be assessed as proportions of: drug discontinuation, and new grade 3 or 4 adverse events. Effectiveness will be assessed as incidence of cholangiographically-diagnosed IC and incidence of any IC-related complication.

The aim of this study is to measure the differences in quality of life and mood of liver transplant recipients in the immediate month post- transplant staying at the Gabriel House of Care staying at a hotel, apartment or rental property. 

The purpose of this study is to evaluate livers transplanted to the recipient by utilizing the non-invasive spectrophotometer for the purposes of obtaining measurements to compare them with the measurements obtained during liver procurement and histological evaluations. 

The purpose of this study is to evaluate genes collected comparing a recipient's serum, a recipient's original liver and the donor liver graft to determine the characteristics of livers that are susceptible versus resistant to recurrent disease, to reduce the likelihood of liver graft failure in the long-term.

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.

Diagnosing sarcopenia using modalities that can be used in routine clinical care is important. Our study will aim to assess the efficacy of the sarcopenia model. If results from this model are highly correlated to the gold standard, CT, then its use will allow for assessment of sarcopenia in routine clinical care.

The purpose of this study is to understanding the mechanisms of weight gain in patients following liver transplantation, action, and indicate approaches to prevent weight gain.

The purpose of this study is to gather information that may improve the medical care of children who need or who have had liver transplants.

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

The purpose of this study is to explore the application of “liquid biopsy” in the diagnosis, prognostication and monitoring of cholangiocarcinoma (CCA) patients undergoing liver transplant.


 

The purpose of this study is to send a simple survey to liver transplant programs in USA to get a better understanding of coagulation and bleeding management during liver transplant.

The aim of this study is to assess the quality of life among a sample of obese liver transplant recipients and compare it between those who underwent sleeve gastrectomy and those who did not.

This is a study of two different approaches for the prevention of CMV disease in liver transplant recipients. The primary purpose is to determine if Preemptive therapy is the same or better than Prophylaxis therapy for the prevention of CMV disease in CMV seronegative recipients that receive a CMV positive liver transplant. Patients meeting study criteria and who have provided informed consent will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg orally once daily for 100 days or preemptive therapy (weekly monitoring for asymptomatic CMV viremia by ...

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 purpose of this study, is to open expanded access at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Patients who have an aggressive, recurring hepatitis C infection following liver transplant, will be given sofosbuvir combined with ribavirin, and pegylated interferon may or may not be added at the discretion of the investigator.

The purpose of this study is to investigate means to identify circulating tumor cells from the portal vein and hepatic vein blood of patients with liver cancer at the time of liver transplantation.

The purpose of this study is to compare the effects of normothermic machine profusion versus static cold storage for preventing preservation-related graft injury in human livers for transplantation.

The purpose of this study is to validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.

The purpose of this study is to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Participants will be randomized to receive 12 or 24 weeks of dosing with the LDV/SOF FDC tablet+ribavirin (RBV).

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 determine the effectiveness of the use of  smartphone app based education, assessment and intervention modules to improve healthy behavior following liver transplant surgery.

This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.

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

This research study is for liver transplant recipients and their respective living donors. The purpose of this study is to see if it is safe for liver recipients to receive one dose of donor reactive T regulatory cells (Tregs), and if the Tregs allows a liver recipient to take less, or completely stop medications normally taken after receiving an organ transplant.

The purpose of this study is to compare functional improvement and caregiver burden pre- and post-liver transplant (LT) in four patient and patient’s primary caregiver dyads, grouped, based on presence or absence of mood symptoms pre-LT.

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 ...

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.

The purpose of this study is to measure the rates of continuing viral presence, following anti-viral therapy with combined Peg-Interferon and Ribavirin in patients that have had a liver transplant, are immune suppressed with Neoral or tacrolimus, and have a recurring infection with the Hepatitis C virus.

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 ...

The purpose of this study is to see if certain pre-transplant markers are able to predict how the kidney will respond after a liver transplant.

This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.

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 primary aim of this study is to determine the accuracy of CAP from Fibroscan in the quantification of liver steatosis in donors using liver biopsies as the gold standard. 
 

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 purpose of this study is to evaluate the degree of change to cardiac strain using speckle tracking echocardiography.

The purpose of this study is to:

1. To determine whether the presence of pleural effusion measured by bedside ultrasound in the immediate pre-liver transplant period is associated with worse postoperative outcome as compared to no pleural effusion
2. To determine the prevalence of pleural effusion in the immediate pre-liver transplant period measured by lung ultrasound, as compared to the prevalence measured by routine pre-transplant chest imaging

The purpose of this study is to evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.

The purpose of the study is to determine if gadolinium cholangiogram provides adequate biliary anatomy information required for surgical decision-making prior to living-related donor right lobe liver transplantation.

This pilot phase I trial studies the side effects and best way to give sirolimus, gemcitabine hydrochloride, and cisplatin in treating patients at high risk for cholangiocarcinoma recurrence after liver transplant or surgery. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sirolimus with gemcitabine hydrochloride and cisplatin may be an effective treatment for patients with a high ...

The purpose of this study is to determine the safety of the SARS-CoV-2 vaccination in patients listed for solid organ transplantation, including heart, lung, liver, kidney, and pancreas.

The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.

The purpose of this study is to assess the safety, tolerability, and dose limiting toxicities of taking a specific combination of immunosuppressant drugs on infused donor-alloantigen-reactive regulatory T cells after liver transplantation, to improve immune function without liver rejection.

The primary purpose of this study is to evaluate diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) PET/MRI OR PET/CT for HCC using surgical histopathology (either resection, transplant or biopsy specimens) or LI-RADS® categorization as gold standard.

The purpose of this study is to determine if the Living Donor Assessment Tool (LDAT) is an effective tool to improve the psychosocial evaluation of potential live kidney and liver donors. The LDAT was developed by the living donation team at the Zweig Family Center for Living Donation at the Mount Sinai Recanati/Miller Transplantation Institute. It assesses important areas of the evaluation process such as motivation (reason) for donation, knowledge of living donation, support, relationship to organ recipient, feelings about donation, stability in life and psychiatric and addiction history and provides a score that can be used to measure the ...

The purpose of this study is to characterize the readily available (circulating in peripheral blood) mediators of cell proliferation in individuals undergoing living liver donation.

The purposes of this study are to prospectively evaluate the effects of a structured, modified Mediterranean diet on post-liver transplant weight gain and development of PTMS, to prospectively evaluate the effects of a structured, modified Mediterranean diet on cardiovascular outcomes post-liver transplantation, and to prospectively evaluate the effects of a structured, modified Mediterranean diet on development or recurrence or de novo NAFLD/NASH in liver-transplant patients.

The purpose of this study is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).

The purpose of this study is to determine agreement between cardiopulmonary exercise testing and cardiac stress testing (SOC) for the identification of subclinical coronary artery disease in liver transplant candidates, to determine agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (SOC) for the identification of cirrhotic cardiomyopathy in liver transplant candidates, and to determine agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test (SOC), for the identification of frailty in liver transplant candidates.

The purpose of this study is to evaluate the effectiveness of vertebral fracture assessment (VFA) in evaluation of asymptomatic fracture in pre-liver transplant patients as compared to the current standard of care using spine x-ray
 

The purpose of this study is to prospectively evaluate the safety and effectiveness of standard of care, individualized, comprehensive weight loss interventions in carefully selected patients with obesity undergoing liver transplant evaluation, including utilization of best lifestyle modifications and guidance to promote a healthy weight, possible medical therapy using FDA-approved weight loss medications and EBMTs with or without concomitant medical therapy.