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Current Research & Innovations

Liver

A Multi-Center Trial to Study Acute Liver Failure "Data and Specimen Collection" Sub-study: A Multi-Center Study of the Safety and Efficacy of N-Acetylcysteine in the Treatment of Acute Live — (Robert Brown, MD, MPH)
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)
A2ALL LADR: Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Living Donor Liver Transplantation — (Robert Brown, MD, MPH)
Achieve 2/3 —The Achieve 2/3 study is for hepatitis C virus-positive, genotype 2 and 3 patients who are naïve to therapy. It involves a new interferon that only has to inject every other week. Therapy lasts for 24 weeks, and involves another 24 weeks of follow-up. (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)
Acute Liver Failure (Pediatrics): Evaluating the Safety and Efficacy of N-Acetylcysteine in the Treatment of Acute Liver Failure Not Caused by Acetaminophen —This multi-center study evaluates the safety and efficacy of N-acetylcysteine in the treatment of acute liver failure not caused by acetaminophen. (Steven Lobritto, MD)
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)
An Open-Label, Randomized, Prospective Multicenter Study to Compare the Efficacy and Safety Among Three Immunosuppressant Treatment Regimes in Patients Receiving a Liver Transplant for End-St — (Robert Brown, MD, MPH)
Chronic Hepatitis B in Children and Adolescents: Determining the Safety and Efficacy of Adefovir Dipivoxil —This phase III, double-blind, randomized, placebo-controlled study evaluates the safety and efficacy of adefovir dipivoxil in children and adolescents (ages 2 to less than 18) with chronic hepatitis B. (Steven Lobritto, MD)
Chronic Hepatitis B with Decompensated Liver Disease: Comparing Oral Antiviral Treatments (Tenofovir Disoproxil Fumarate, Emtricitabine with Tenofovir Disoproxil Fumarate, and Entecavir) —This phase 2, double-blind, multi-center, randomized study compares three oral antiviral treatments for chronic hepatitis B with decompensated liver disease: (1) tenofovir disoproxil fumarate, (2) emtricitabine with tenofovir disoproxil fumarate, and (3) entecavir. (Robert Brown, MD, MPH)
Chronic Hepatitis C and Hepatic Fibrosis: Assessing the Safety and Efficacy of GI262570 in Patients Who Have Failed Prior Antiviral Therapy —This double-blind, randomized, placebo-controlled, multi-center, phase II, parallel dose-ranging study will assess the antifibrotic activity of GI262570 in chronic hepatitis C patients with hepatic fibrosis who have failed prior antiviral therapy. (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)
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)
Hepatitis B Virus Inflammatory Markers —The purpose of this study is to determine if there is a pattern of serum markers that can predict the degree of inflammation on liver biopsy, if the level of the inflammatory markers decline during antiviral therapy, and if the decline of the level of inflammatory marker(s) correlates with clinical and biochemical improvement in patients with decompensated cirrhosis. (Abby Siegel, MD)
Hepatitis C: Comparing Treatments of VX-950 Combined with Peginterferon Alfa-2a (Pegasys) with and without Ribavirin (Copegus) —This phase 2 study evaluates two treatments for hepatitis C: (1) VX-950 combined with peginterferon alfa-2a (Pegasys) with ribavirin (Copegus), and (2) VX-950 combined with peginterferon alfa-2a (Pegasys) without ribavirin (Copegus). (Robert Brown, MD, MPH)
Hypothermic Machine Preservation of Liver Grafts for Transplantation — (James Guarrera, MD)
Infergen - Valeant 402 (ENHANCE) —The primary objective of this trial is to compare the efficacy and safety of Infergen plus ribavirin vs. peginterferon plus ribavirin in patients with chronic hepatitis C virus genotype I who were partial responders after treatment with peginterferon/ribavirin. (Robert Brown, MD, MPH)
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 Disease: Examining Pulmonary Vascular Complications —This study will examine the association of genetic polymorphisms with pulmonary vascular disorders in patients with advanced liver disease. Funding for this study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases. ( , )
Liver Failure: Evaluating the Efficacy, Safety, and Tolerability of Rifaximin in Preventing Hepatic Encephalopathy —This multi-center, randomized, double-blind, placebo-controlled trial evaluates the efficacy, safety, and tolerability of Rifaximin (550 mg 2x/day for 6 months) in preventing hepatic encephalopathy. (Robert Brown, MD, MPH)
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)
Phase II Study of a Biochemically Synergistic Regimen for Advanced Adenocarcinoma of the Biliary Tree with Gemzar, Taxotere and Xeloda (GTX) —After initial presentation of the GTX regimen (in pancreatic cancer) a number of practitioners began using the regimen for pancreatic cancer patients. Several of these investigators began using the same regimen for patients with unresectable and metastatic biliary tree cancers such as cholangiocarcinoma. Personally, our group has treated 5 patients with the GTX regimen, and have documented 2 partial responses and 1 stable disease out of 3 patients with cholangiocarcinoma and 2 with gall bladder cancer. We therefore believe that it will show efficacy in this disease. The primary goals of this trial are to determine response rate to this regimen in patients with metastatic biliary tree cancers (stage 4) and to determine response rate to this regimen in patients with unresectable stage 3 biliary cancers. (Robert Fine, MD)
Salix —The primary objective of this multi-Center, randomized, double-blind, placebo-controlled trial is to compare the maintenanace of remission from hepatic encephalopathy during 6 months of treatment with rifaximin or placebo. (Robert Brown, MD, MPH)
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)
Taribavirin (VALEANT 204) —Comparison of weight-based doses of a new drug called Taribavirin Combined with Peginterferon Alfa 2b versus Ribavirin Combined with Peginterferon Alfa 2b in therapy-naive patients with chronic hepatitis C Virus Genotype 1 infection. (Robert Brown, MD, MPH)
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, )