Current Research & Innovations

Liver Transplant

• A multicenter, randomized, open label study to compare the development of liver fibrosis at 12 months after transplantation for hepatitis C cirrhosis in patients receiving either Neoral® or tacr — (Robert Brown, MD, MPH)
• Acute Liver Failure (ALF) Adult —The Acute Liver Failure Study is a multi-center, multi-national collaborative study aimed at identifying, characterizing, and developing management strategies for adults who present with acute liver failure (ALF). The primary focus of the ALF study group is to collect, maintain, analyze, and report clinical, epidemiological, laboratory, and outcome data in adults with ALF. Including information derived from biospecimens (Robert Brown, MD, MPH)
• Adefovir Plus Vaccination Efficacy in Recipients of Livers Testing Positive for Hepatitis B Core Antibody —This study evaluates the safety and efficacy of adefovir dipivoxil (ADV) plus vaccination in liver transplant recipients, when the recipient is negative for hepatitis B infection but receives a liver that has tested positive for hepatitis B core antibody (HBcAb). (Brown Robert, MD, MPH)
• Adult-to-Adult Living Donor Liver Transplantation Cohort Study —The primary objective of the A2ALL study is to determine whether the decision to undergo Living Donor Liver Transplantation (LDLT) is beneficial for the patients who choose LDLT. The principal hypothesis is that receipt of a living liver allograft leads to better long-term outcomes for liver transplant candidates than pursuit of cadaveric transplant. This is a study of the decision to perform LDLT. Several different patient outcomes will be considered: comparison of mortality between LDLT and non-LDLT recipients; retrospective Hepatitis C Virus (HCV) study; retrospective Hepatocellular Carcinoma (HCC) study; Scientific Registry of Transplant Recipients data validation study; retrospective post-surgical complications study; and a retrospective resource utilization study. (Jean Emond, MD)
• Adult-to-Adult Living Donor Liver Transplantation Cohort Study: Genomics and Regeneration in the Transplant Setting —Liver graft recovery and function correltes with numerous donor-related variables, the extent of cold ischemia/reperfusion injury, and the recipient status at the time of transplantation. Regeneration is required of cadaveric liver grafts to restore lost liver mass due to injury. Living donation minimizes cold ischemic injry, but the allograft still develops an inflammatory response, and must undergo considerable regeneration. In parallel, the liver graft must continue to function and support the recipient at the time of transplantation. Failure to regenerate may affect liver function, which will utlimately impact on graft and recipient survival. It is possible that mechanisms of inflammation and ischemic tissue injury occurring in the early post-transplantation period drive molecular networks for liver regeneration and tissue repair required for graft and patient survival. We hypothesize that failure to initiate the molecular pathways of regeneration in the human living or deceased donor liver will result in poor graft function. Identifying a patter of expression of specific genes or subset of genes associated with poor outcome may provide important information for the development of interventional strategies at the time of transplantation. (Jean Emond, MD)
• Advanced Liver Failure (ALF) Pediatric —The Pediatric Acute Liver Failure (PALF) Study is a multi-center, multi-national collaborative study aimed at identifying, characterizing, and developing management strategies for infants, children, and adolescents who present with acute liver failure (ALF). It includes 19 clinical centers and a data coordinating center. The primary focus of the PALF study group is to collect, maintain, analyze, and report clinical, epidemiological, laboratory, and outcome data in children with ALF. Including information derived from biospecimens. (Lobritto Steven, MD)
• An Open Label, Multi-Center Study of Peg Intron and Ribavirin in Post-Orthotopic Liver Transplant Patients with Recurrent Hepatitis C Virus (PROTECT) —To determine the sustained virologic response after treatment with PEG interferon + ribavirin in patient s with recurrent HCV after liver transplantation. (Robert Brown, MD, MPH)
• Drug Treatment for Transplant Candidates —Dr. Haller's Grant (Robert Brown, MD, MPH)
• Gilead-0108 —Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects with Decompensated Liver Disease (Abby Siegel, MD)
• Hypothermic Machine Preservation of Liver Grafts for Transplantation — (James Guarrera, MD)
• Live Donor Education —The purpose of this trial is to educate individuals awaiting liver transplantion about live donor liver transplantation (LDLT). This is a 3 phase trial. Phase I will assess the recipients knowledge about LDLT prior to receiving education regarding LDLT. Phase II is the intervention phase in which education materials are provided to the subjects. Phase III is a reassessment of subjects knowledge regarding LDLT post education. (Dianne Lapointe-Rudinow, ANP)
• Liver Perfusion —The purpose of this pilot study is to evaluate continuous hypothermic machine perfusion of cadaver liver grafts for transplantation as a method of organ preservation prior to transplantation. (James Guarrera, MD)
• Liver Transplant and Hepatitis B: Determining the Efficacy of Adefovir Dipivoxil (ADV) and Vaccination in Recipients of Livers Testing Positive for Hepatitis B Core Antibody —This study evaluates the safety and efficacy of adefovir dipivoxil (ADV) plus vaccination in liver transplant recipients, when the recipient is negative for hepatitis B infection but receives a liver that has tested positive for hepatitis B core antibody (HBcAb). (Robert Brown, MD, MPH)
• Liver Transplant and Hepatitis C: Evaluating Pegylated Interferon Alfa-2b and Ribavirin in Hepatitis C Recurrence Therapy —This study evaluates the safety and efficacy of pegylated interferon alfa-2b and ribavirin after an orthotopic liver transplant for patients who have recurrences of the hepatitis C virus. (Robert Brown, MD, MPH)
• Liver Transplant: Determining the Efficacy and Safety of a Long Term Calcineurin Inhibitor-Free Maintenance Regimen —This prospective, open-label, multi-center, randomized trial evaluates the efficacy and safety of a long term calcineurin inhibitor-free maintenance regimen for patients who have received an orthotopic liver transplant. The maintenance regimen replaces calcineurin inhibitors with mycophenolate mofetil and sirolimus, immunosuppressants that show reduced side effects. (Robert Brown, MD, MPH)
• Liver Transplant: Molecular Profiling and Immunomodulatory Intervention (Year 1) — (Jean Emond, MD)
• Pediatric Liver Transplant: Collecting Scientific Data —This multi-center, prospective study will collect scientific data on pediatric liver transplantation. (Steven Lobritto, MD)
• Studies of Pediatric Liver Transplantation (SPLIT), a Multi-Center, Prospective Study to Collect Scientific Data on Pediatric Liver Transplantation —Studies of Pediatric Liver Transplant, (SPLIT), is a research effort that was organized in 1995 by a group of physicians and surgeons committed to the success of liver transplants in children. The group represents a collaborative effort between transplant centers in the United States and Canada, and works to collect and analyze information required to advance the science of pediatric liver transplant. (Steven Lobritto, MD)
• Treatment and Addiction Project (TAP) —The purpose of this trial is to evaluate/compare duration of abstinence and outcomes in liver transplant candidates with substance use disorders who are randomized to receive a 12 session telephone intervention in addition to standard of care (SOC) treatment vs. SOC treatment alone. (Deborah Haller, )