Clinical Research Directory

A Study of SIPLIZUMAB in AILD and LT Patients

There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-cluster of differentiation 2 (CD2) monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT. Up to eight (8) subjects will receive siplizumab 0.6 mg/kg/dose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses. All subjects will be followed in the study for 12 months post-LT.

Angiotensin 2 for AKI After OLT

Kidney injury is a common complication following liver transplantation and is associated with a higher complication rate and increased risk of death. While there are many factors that likely contribute to kidney injury in the perioperative period, a relative low serum level of angiotensin 2 (Ang 2) (a protein hormone that causes blood vessels to narrow) found in patients with liver cirrhosis (late stage of liver damage) may increase their risk of developing acute kidney injury (sudden episode of kidney failure or damage). We propose to investigate how early administration of Ang 2, a new vasopressor drug approved by the FDA in December 2017 for patients with low blood pressure, during the intra-operative period of liver transplant surgery affects the rate of kidney injury after transplantation. Patients who are deemed appropriate candidates for the study will be randomized 1:1 to the treatment and control groups. The intervention period of the study will occur in the operating room during transplant surgery and will be performed by their anesthesiologists. In the Treatment group, patients will receive Ang 2 infusions in addition to other standard vasopressors while patients in the control group will receive standard vasopressors alone. The infusion of Ang 2 in the treatment group will continue through the duration of the surgery and will be stopped prior to leaving the operating room. Both the treatment group and the control group will then be followed for 14 days to evaluate rates of kidney injury and to look for any complications. The follow up period will be extended to 28 days to look at in-hospital mortality rates in both groups. The daily follow up analysis will occur while the enrolled patients are inpatient following their transplantation surgery and will be done by looking at lab values and other data that is routinely gathered by their managing teams. This study will serve as a pilot study to evaluate feasibility of our protocol and to collect some preliminary data on the use of Ang 2 in this patient population. As such we plan to enroll approximately 30 patients who have accepted an offer to receive a donor liver. We hope to reach our goal enrollment within 5 months of starting the study.

Adverse Outcomes and Mortality in Liver Transplant

Prospective natural history pilot study to explore the link between muscle composition using an MRI-based Muscle Assessment Score (MAsS) and adverse outcomes in liver transplant candidates.

Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease

Remote healthcare monitoring for cirrhosis has shown promise in overcoming barriers to accessing specialty care, improving healthcare quality, and reducing mortality. The LiverWatch study is investigating whether a remote nutrition, physical activity, and education intervention can improve health outcomes in those with cirrhosis. In this clinical trial, individuals will be randomized to either enhanced usual care or the LiverWatch intervention. Both groups are given fitbits and asked to increase their step counts. Those in the Liverwatch group will be incentivized for increase their physical activity while also undergoing a personalized nutrition intervention and weekly symptom monitoring and cirrhosis education.

Disparities Among Liver Transplant Patients

The purpose of this study is to inform healthcare interventions to reduce the disparities in liver transplant listing and in transplantation.

HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease

This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.

LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant

Liver transplantation is increasingly performed for older adults with multiple comorbidities. Medication adherence is key to maintaining proper function of the transplanted liver and optimize health; however, adhering to post-transplant treatment is complex. This trial will study how available technology combined with transplant center resources and caregiver support can optimize medication adherence, quality of life, and health outcomes among new liver transplant recipients at 3 centers.

Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years

Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process. This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.

SALT in Adolescents With End-stage Liver Disease

End-stage liver disease is synonymous with advanced liver disease, liver failure, and decompensated cirrhosis, and their disease progression is generally irreversible. Unlike other end-stage diseases, liver transplantation is a definitive and potentially curative treatment for ESLD. However, due to clinical and social factors such as the shortage of donor livers, the number of patients who can be transplanted is far less than the number of waiting patients. About 14% of patients die each year while waiting, and about 10% of patients are too sick to be transplanted. Although changes in organ allocation policies and popularization of living donor liver transplantation have significantly reduced the waiting time and mortality of infant recipients under 2 years old. Pre-transplant mortality in children older than 6 years remains high. Therefore, expanding the donor liver pool is an urgent need to treat patients with adolescent end-stage liver disease (AESLD). In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above patients.Based on the experience of clinical operation, our center proposes and designs the clinical research of sequential adolescent left lateral lobe liver transplantation (SALT) for the treatment of AESLD. On the basis of RAPID, the safety and efficacy of sequential juvenile left lateral lobe liver transplantation were evaluated for the above patients.

Real World Study of End-stage Liver Disease in China

The aims of this study are exploring the current situation of end-stage liver disease in China, and the optimization of diagnosis and treatment. Liver cirrhosis often accompanied by a series of complications. Therefore, it is necessary to standardize the diagnosis and treatment of liver cirrhosis and its complications. End-stage liver disease mainly refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that liver function can not meet the physiological needs of human body. This study is a single-center, prospective and observational real-world study aimed at investigating and analyzing the current diagnosis and treatment of liver cirrhosis and end-stage liver disease in China.