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Liver Transplantation clinical trials

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NCT ID: NCT03823768 Completed - Clinical trials for Liver Transplant; Complications

Envarsus Neurotoxicity Burden in Liver Transplant Patients

Start date: January 31, 2020
Phase: Phase 4
Study type: Interventional

This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.

NCT ID: NCT03800576 Completed - Clinical trials for Liver Transplantation

Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression

Start date: June 6, 2019
Phase:
Study type: Observational

Genetic polymorphism and numerous clinical factors could influence tacrolimus pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a challenge. The study's objective is to identify the genetic and clinical factors that can influence clinical outcome in liver transplant.

NCT ID: NCT03799770 Completed - Clinical trials for Liver Transplant; Complications

ONSD and Neurotoxicity in Liver Transplant

Start date: January 1, 2019
Phase:
Study type: Observational

This is a diagnostic test accuracy study. The investigators measure optic nerve sheath diameter (ONSD) by ultrasound on the eye during living donor liver transplantation operation at 5 minutes after reperfusion to predict the occurrence of early tacrolimus neurotoxicity after liver transplantation. We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion.

NCT ID: NCT03781414 Completed - Clinical trials for Liver Transplant Rejection

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension

CONTRAIL I
Start date: October 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study was to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 dose regimens in liver transplant recipients.

NCT ID: NCT03775863 Completed - Clinical trials for Liver Transplant Disorder

AFP Model and Liver Transplantation.

Start date: November 11, 2017
Phase:
Study type: Observational

Background & Aim: Presence of microvascular invasion (mvi) in the explanted liver defines a higher risk of recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT). The aim of this study is to evaluate pre LT selection models of HCC recurrence specifically in patients without mvi in the explanted liver. Methods: Three multicenter cohorts are going to be included: a Latin American, a French and an Italian cohort of consecutive adult patients with HCC a first LT performed during two different periods: 2005-2011 and 2012-2016. AFP model is going to be compared against Milan and San Francisco criteria according to each models accuracy and prediction of HCC recurrence among patients without microvascular invasion in the explanted liver considering these candidates as "Low-risk patients". Multivariate Cox regression analysis, with hazard ratios (HR) and 95% confidence intervals (CI) for 5-year recurrence is going to be done with Competing Risk Regression analysis and corresponding Subhazard Ratios (SHR).

NCT ID: NCT03756948 Completed - Bleeding Clinical Trials

Viscoelastic Tests-Guided Therapy In Liver Transplantation

VETLT
Start date: January 1, 2007
Phase: N/A
Study type: Interventional

BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation. METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.

NCT ID: NCT03665766 Completed - Clinical trials for Liver Transplantation

Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation

Start date: May 15, 2014
Phase:
Study type: Observational

Background and Aim: The immunosuppression influence on the response to antiviral therapy (AVT) for recurrent hepatitis C virus (HCV) infection in liver transplant (LT) recipients remains controversial, especially for the rarely investigated genotype 4.This study aims to compare the effects of the two widely used calcineurin inhibitors(CNIs)(Cyclosporine A (CsA) and tacrolimus (Tac)) on the therapeutic response to different AVT regimens. Method: In126 living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) (n= 44), group two received the direct antiviral agent (DAA) sofosbuvir plus RBV (n=52) and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV(n=30) each group was further subdivided according to primary immunosuppression (CsA or Tac). The sustained virological response (SVR) and relapse rates were considered the primary therapeutic outcomes of AVT. The virological response guided therapy end points for AVT were considered the secondary outcomes.

NCT ID: NCT03639623 Completed - NAFLD Clinical Trials

Safety, Tolerability and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With NAFLD

Start date: February 25, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.

NCT ID: NCT03636321 Completed - Liver Transplant Clinical Trials

Stented Biliary Anastomosis in Living Donor Liver Transplantation

Start date: August 10, 2018
Phase: N/A
Study type: Interventional

Determination of biliary complications in stented group compared to duct to duct anastomosis without stent

NCT ID: NCT03634566 Completed - Clinical trials for Liver Transplant; Complications

Effect of N_Acetylcysteine on Liver Functions in Donors in Living Liver Transplantation

Start date: April 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

our practice for the past 10 years we have noticed a transitional impairment of liver function (elevated liver enzymes, total and direct bilirubin, and elevated serum lactate levels) following donors' liver resection. Several drugs have been investigation on liver regeneration , proven benefit of N-Acetylcysteine (NAC) on rats with steatohpatitis