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Liver Transplantation clinical trials

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NCT ID: NCT01909401 Completed - Clinical trials for Liver Transplantation

Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation

Start date: June 2013
Phase: Phase 0
Study type: Interventional

Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications for those preparing for a liver transplant. The purpose of this study is to determine whether those individuals who require liver transplantation for Hepatitis C, genotype I, who are undergoing liver transplantation may successfully get rid of their virus before the transplant by taking three medicines, peginterferon, ribavirin, and boceprevir, up until the time of the liver transplant surgery. If successful, the Hepatitis C virus will not re-infect the new liver that they receive and they will not require therapy for Hepatitis C after liver transplantation. This study involves the use of peginterferon alfa-2b, ribavirin, and boceprevir, all of which are approved for the treatment of genotype I Hepatitis C. Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic liver transplantation will lead to rapid HCV RNA clearance of genotype I infected individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new transplanted graft and prevent graft infection posttransplantation.

NCT ID: NCT01890460 Completed - Clinical trials for Liver Transplantation

Evaluation of Liver Disease With Elastography Measurements in Patients Undergoing Liver Transplant Surgery

SupersonicOR
Start date: June 2013
Phase: N/A
Study type: Observational

The purpose of the study is to compare ultrasound measurements of the liver obtained prior to surgery on the skin to measurements obtained during surgery directly on the diseased liver. The objective is to determine if ultrasounds of the liver on the skin can provide accurate measurements of disease of the liver to provide an alternative option to liver biopsies.

NCT ID: NCT01889758 Completed - Clinical trials for Kidney Transplant Recipients

Pharmacokinetic Studies of Tacrolimus in Transplant Patients

PK
Start date: June 2013
Phase: Phase 4
Study type: Interventional

The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.

NCT ID: NCT01888432 Completed - Clinical trials for Liver Transplantation

Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

NCT ID: NCT01887171 Completed - Clinical trials for Liver Transplantation

Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus

PATAC
Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the Tacrolimus added to histidine-tryptophan-ketoglutarate (HTK) solution given through intraportal and intraarterial infusion during back-table procedure is capable of reducing the degree of early allograft liver dysfunction, as assessed by postoperative levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), during first 7 postoperative days and by serum and histochemical markers of liver injury and inflammation.

NCT ID: NCT01886664 Completed - Clinical trials for Liver Transplantation

Comparison of PRS According to Inhalation Agent During LDLT

Start date: December 2012
Phase: Phase 4
Study type: Interventional

The investigators tried to evaluate the effect of desflurane on the incidence of postreperfusion syndrome during living donor liver transplantation surgery. The investigators used sevoflurane as a comparison.

NCT ID: NCT01884038 Withdrawn - Liver Transplant Clinical Trials

Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients

Start date: June 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Patients undergoing orthotopic liver transplant will experience some degree of clinical and/or biochemical hepatic dysfunction. This early injury is known as primary graft dysfunction and varies from minor abnormalities to primary nonfunction. Prostaglandin-class drugs, including prostacyclin and its analogs, could represent an important advance toward the goal of reducing transplant related morbidity, mortality and associated costs by providing these benefits.

NCT ID: NCT01841632 Terminated - Clinical trials for Liver Transplantation

Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation

Start date: April 2013
Phase: Phase 1
Study type: Interventional

MultiStem ® is a new biological product, manufactured from human stem cells obtained from adult bone marrow. Factors expressed by MultiStem cells are believed to regulate immune system function and augment tissue repair. Standard of care pharmacological immunosuppression after liver transplantation can achieve reasonable survival of liver grafts and patients. The side effects of this treatment, however, are clinically significant and diminish the overall success of organ transplantation as a curative therapy. It is therefore the objective of this study to implement cellular immunomodulation therapy with MultiStem as an adjunct to standard pharmacological immunosuppression with the ultimate goal of significantly reducing drug-based immunosuppression. As this is the first study with MultiStem in this subject population it has been designed as a safety and feasibility trial. However, first evidence of a potential benefit for this patient population will be explored cautiously.

NCT ID: NCT01840514 Recruiting - Liver Transplant Clinical Trials

Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.

Start date: December 2012
Phase: N/A
Study type: Observational [Patient Registry]

The stress of orthotopic living donor liver transplantation in patients with cirrhosis could induce worsening of an already recorded myocardial dysfunction or may be associated with a new myocardial dysfunction in patients previously having normal myocardial functions, therefore this study will be designed for intra-operative detection of new onset ventricular dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver transplant recipient and the possible contribution of several hemodynamic and oxygenation parameters in the generation of any cardiovascular function impairment will be also investigated and to determine the impact of ventricular dysfunction on early (7 PO days) graft function, 28 days survival and patient outcomes.

NCT ID: NCT01836718 Active, not recruiting - Clinical trials for Liver Transplantation

Assessment of Intrahepatic Hepatitis C Virus (HCV) RNA Levels at the Time of Liver Transplantation

Start date: June 2013
Phase: N/A
Study type: Observational

The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver transplantation in patients receiving antiviral therapy while on the liver transplant waiting list. This will eventually be correlated with the degree of hepatic fibrosis present within different geographic sites in the cirrhotic liver. Tissue samples will be obtained from the patient's liver explant as well as hilar lymph nodes. Upon the removal of the cirrhotic liver at the time of transplantation, the explant will be biopsied multiple times in different segments of the liver and preserved for viral detection studies as well as analysis of the degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be obtained for viral detection at the time of transplantation. Serum HCV RNA levels will also be obtained at 1 month, 3 months and 6 months post liver transplantation. Study Hypotheses: - Virological relapse or non-response is higher is patients with cirrhosis due to failure of antiviral medication to concentrate adequately in a fibrotic liver having an altered sinusoidal micro-architecture - HCV may persist in different geographic regions of the fibrotic liver in part predicated on blood supply to that area and this may have an effect on overall virological response. These differences in viral persistence and detection may exist in different lobes of the liver or even within a few centimeters within the same portion of the liver parenchyma. - PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in patients receiving antiviral therapy and may account for virological relapse post-therapy - There may be varying degrees of fibrosis within the same cirrhotic liver which may impact on hepatic synthetic function and antiviral response to treatment.