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Liver Transplantation clinical trials

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NCT ID: NCT01139203 Recruiting - Hepatitis B Clinical Trials

Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

Start date: August 2009
Phase: N/A
Study type: Interventional

Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.

NCT ID: NCT01125020 Recruiting - Clinical trials for Hepatocellular Carcinoma

Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

Start date: December 2008
Phase: N/A
Study type: Interventional

The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.

NCT ID: NCT01065584 Recruiting - Clinical trials for Liver Transplantation

An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance

OSCITT
Start date: February 2010
Phase: N/A
Study type: Observational

In experimental and clinical settings it has been shown that transplant tolerance is possible. It has been suggested that regulatory T cells play a beneficial role in the establishment of tolerance. Calcineurin inhibitors may inhibit development of regulatory T cells. However, the influence of calcineurin inhibitors on markers of transplant tolerance has not been studied in patients undergoing liver transplantation. Currently the investigators conduct a study to evaluate the safety and efficacy of a calcineurin inhibitor free immunosuppression in patients undergoing liver transplantation. In this study measurements of immune function and CD4+CD25high-Foxp3+-Il2/CD8+ status will also be performed. In parallel these measurements should be compared to a group of patients undergoing standard immunosuppression including calcineurin inhibitors.

NCT ID: NCT01034345 Recruiting - Clinical trials for Liver Transplantation

Effect of Rapamycin on Tolerance-related Biomarkers on Stable Liver Transplant Recipients

Start date: November 2009
Phase: Phase 2
Study type: Interventional

In contrast to calcineurin inhibitors, sirolimus is known to exert remarkable tolerance-promoting properties in multiple animal transplant models. Whether sirolimus is capable of enhancing tolerance-related pathways and/or promoting complete withdrawal of immunosuppressive drugs in human transplant recipients has not been previously addressed. The goal of the investigators study is to evaluate the effects of sirolimus on previously identified tolerogenic pathways in humans and, indirectly, to assess the capacity of this drug to enhance the proportion of liver recipients undergoing successful immunosuppression weaning.

NCT ID: NCT01023542 Recruiting - Clinical trials for Liver Transplantation

CNI-free "Bottom"-up Immunosuppression in Patients Undergoing Liver Transplantation

BUILT_01
Start date: June 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the trial is to evaluate efficacy and safety of delayed introduction (up to 30 days post-transplantation in patients without signs of acute rejection that had received an aIL-2 induction and MMF) of either cyclosporine or everolimus versus a 5-day delay of cyclosporine in combination with MMF.

NCT ID: NCT00890253 Recruiting - Clinical trials for Liver Transplantation

Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation

CILT
Start date: January 2010
Phase: Phase 2
Study type: Interventional

A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.

NCT ID: NCT00333645 Recruiting - Clinical trials for Liver Transplantation

Prophylaxis With Caspofungin in High-Risk Liver Transplantation

Start date: October 2003
Phase: Phase 2
Study type: Interventional

This is a non-comparative, open, multisite prospective estimation study to evaluate the efficacy and safety of caspofungin in the prophylactic treatment of adults who have received an orthotopic liver transplant and are at high risk of developing an invasive fungal infection. It is expected that the proportion of high-risk liver transplant recipients who develop a documented (proven or probable per European Organization for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG] modified criteria) invasive fungal infection during the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. It is also expected that the incidence of serious drug-related adverse events will be less than 25%.

NCT ID: NCT00147459 Recruiting - Hepatitis B Clinical Trials

Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

Start date: September 2005
Phase: N/A
Study type: Interventional

Aim/Background: This study aims to investigate the necessity and efficacy of a hepatitis B virus (HBV) vaccine booster in children after liver transplantation. A universal mass vaccination program of HBV was launched for 20 years in Taiwan. The coverage rate is high and the effect is great. The carrier rate of the population under vaccine coverage decreased from 10-15% to < 1%. In Taiwan, most children who receive organ transplantation were vaccinated with HBV vaccine in infancy and well before the transplantation procedure. This vaccination background information on Taiwanese children is quite unique and not similar to the other countries in the world. The antibody generated by the vaccine usually wanes after a certain period even in normal subjects, let alone in subjects who receive organ transplantation and immunosuppressive agents after transplantation. At present, Taiwan is still an HBV hyperendemic area and the risk of exposure to HBV cannot be overlooked. Should children be given a booster dose of HBV vaccine after transplantation? And how about the immunogenicity of this booster dose in these immunocompromised hosts? If these children cannot obtain an adequate antibody titer, will the risk of HBV infection increase? This study is designed to answer these questions. As a pediatric hepatologist, the author's routine work is to take care of children who underwent liver transplantation. To take advantage of this, the investigators decided to study the efficacy and necessity of HBV booster vaccine in these patients. However, the results of this study should be able to be applied to any kind of solid organ transplanted patients. Method: The anti-hepatitis B surface antigen (HBs) titer will be checked in patients who received liver transplantation > 1 year ago. If the titer is < 10 IU/L, a booster dose will be administered. The humoral (anti-HBs) and cellular immunity (by ELISPOT to assay T and B cell specific proliferation) and cytokine assay will be done in these patients before and after the booster dose. A three-year follow-up will be performed to monitor the HBV infection in these patients. Expected Results: The investigators expect for those who survive one year more after liver transplantation to yield a relatively good response to HBV booster under adequate immunosuppression.