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Liver Transplantation clinical trials

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NCT ID: NCT06455280 Not yet recruiting - Cirrhosis, Liver Clinical Trials

SIPLIZUMAB in AILD and LT

SET-SAIL
Start date: June 1, 2024
Phase: Phase 1
Study type: Interventional

There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-CD2 monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT. Up to eight (8) subjects will receive siplizumab 0.6 mg/kg/dose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses. All subjects will be followed in the study for 12 months post-LT.

NCT ID: NCT06424808 Not yet recruiting - Clinical trials for Liver Transplantation

Pilot Study for the Validity of a Content-based Information Provision Tool Aimed at Improving the Hospitalization Experience of Liver Transplant Patients

Start date: May 21, 2024
Phase: N/A
Study type: Interventional

The investigators aim to evaluate the improvement of the inpatient experience and the usability of a content-based tool (a brochure). This involves consolidating video content for inpatients on a single website and providing access to it via QR codes in a brochure format. [Patients] Considering this as a pilot study, the investigators plan to recruit around 30 participants. Both the experimental and control groups will receive standard care and information, with the experimental group additionally receiving the brochure. Random assignment will be used for the experimental and control groups. Surveys and interviews will be conducted to assess changes in patient experience and usability before and after providing the brochure. [Medical Staff] Among the medical staff involved in the liver transplant surgical process, researchers will select participants based on their degree of involvement with the intervention subjects. After obtaining their consent, interviews will be conducted concerning patient experiences and the brochure.

NCT ID: NCT06418893 Recruiting - Clinical trials for Liver Transplant Recipients

Effect of TCI Propofol on Liver Transplant (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients.

Start date: August 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Both isoflurane and propofol are being used to give anaesthesia for living donor liver transplant in our institute. Propofol when compared to isoflurane has advantages like early awakening from anaesthesia, reduced nausea, vomiting in the postoperative period. Propofol also has antioxidant properties. Because of its antioxidant properties propofol may have a protective effect against oxidative stress and ischemia reperfusion injury in major organs during liver transplant surgery. However, there are no studies showing the effect of isoflurane and propofol on Intraoperative hemodynamics and postoperative liver and kidney functions.Thus, we are conducting this study to know the effect of these agents on intraoperative hemodynamics and postoperative liver and kidney function.

NCT ID: NCT06409637 Not yet recruiting - Liver Cancer Clinical Trials

FOLFOX Plus Lenvatinib Adjuvant Therapy for Hepatocellular Carcinoma Post-Liver Transplantation

Start date: January 1, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

Liver transplantation not only removes the liver tumor (seed) but also eliminates the underlying diseased liver (soil), making it an essential therapeutic approach for hepatocellular carcinoma (HCC). However, the tumor recurrence post-liver transplantation significantly jeopardizing the long-term survival of transplant recipients. Given the scarcity of donor livers, exploring effective measures to prevent tumor recurrence after liver transplantation holds significant clinical and societal value. Currently, there is no consensus on adjuvant therapy for preventing tumor recurrence post-liver transplantation for HCC, and the quantity and quality of studies on systemic chemotherapy are limited. In recent years, administration of the FOLFOX regimen combined with lenvatinib has been widely used in the treatment of advanced HCC, showing remarkable efficacy. The aim of this study is to investigate the efficacy and safety of adjuvant chemotherapy with FOLFOX combined with lenvatinib in preventing tumor recurrence after liver transplantation for HCC beyond Milan criteria.

NCT ID: NCT06409507 Completed - Clinical trials for Hepatocellular Carcinoma

Research and Application for New Clinical Diagnosis and Treatment System for HBV Related HCC Liver Transplantation

Start date: January 1, 2015
Phase:
Study type: Observational

The study evaluated the protein expression levels of FK506-binding protein 12 (FKBP12) in hepatocellular carcinoma (HCC) and paracancerous tissues using immunohistochemistry (IHC). This study aimed to determine the role of FKBP12 in the outcome of liver transplantation recipients with HCC, especially those exceeding the Milan criteria. In addition, we explored how sirolimus administration affected LT recipients'prognosis depending on different FKBP12 expression, aiming to provide some advice for clinical sirolimus application after LT.

NCT ID: NCT06400771 Recruiting - Clinical trials for Liver Transplant; Complications

Safety of DNP007 in Healthy Subjects

Start date: June 10, 2024
Phase: Phase 1
Study type: Interventional

This clinical trial evaluated the safety, tolerability, pharmacokinetic properties, and immunogenicity of DNP007 when administered as a single dose. Since this is a phase 1 study for exploratory evaluation, to the extent that it meets the study objectives, In order to proceed with the minimum number of subjects, a total of 12 people, 3 for each dose group, was planned as the target number.

NCT ID: NCT06386198 Recruiting - Pediatric ALL Clinical Trials

HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients

HEAL-Tx:ToC
Start date: March 3, 2024
Phase: N/A
Study type: Interventional

The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM.

NCT ID: NCT06382740 Recruiting - Clinical trials for Liver Transplantation

Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years

Over70-LT
Start date: October 1, 2022
Phase:
Study type: Observational

Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process. This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.

NCT ID: NCT06371924 Not yet recruiting - Clinical trials for Liver Transplantation

Immunometabolism of Machine Perfusion Strategies

iMaps
Start date: April 2024
Phase: N/A
Study type: Interventional

There are not enough donated livers for everybody who needs one, and as a result, thousands of patients worldwide are waiting for liver transplants, with many dying while waiting for a life-saving organ. One reason for this shortage is that some usable livers from donors who are considered of high risk are being thrown away out of concern that they might not work well after transplantation due to a problem called ischaemia reperfusion injury (IRI). The discarded organs are mostly those coming from donors who have died due to cardiac arrest (called 'donation after circulatory death' or DCD), with only 27% of them being used in the UK. The quality of these DCD organs could be improved by changing how they are preserved after being removed from the donor. The most commonly used strategy is still to remove the livers and put them in an icebox ('static cold storage' or SCS). The alternative approaches, which are more complex and expensive, but that can also improve the quality of the DCD livers, involve using machines to pump fluids through the livers ('machine perfusion' or MP). There are three MP methods being used in patients: 1) normothermic regional perfusion (NRP), which involves pumping the donor's blood through the liver after the donor has died but the liver is still in the donor's body; 2) normothermic machine perfusion (NMP), in which the liver is pumped with blood outside of the donor's body; and 3) hypothermic machine perfusion (HOPE), which is also used outside of the donor's body by pumping cold fluid into the liver. HOPE and NRP have been shown to improve how well DCD livers function after transplantation. NMP can also improve the quality of the DCD livers, but its main advantage is that it allows confirming that the donated liver functions well before proceeding with the transplant. Until now, there has not been a proper comparison of these methods, and the doctors do not understand well the mechanisms through which MP improves the quality of the DCD livers. The iInvestigators plan to conduct a study where 36 DCD human livers will be split into three groups: SCS, NRP, and HOPE. After that, they will be put in NMP to confirm that they are good enough to be transplanted and to study the mechanisms through which NRP, SCS and HOPE work.

NCT ID: NCT06357455 Not yet recruiting - Liver Transplant Clinical Trials

Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery

PLFLTS
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Intraoperative cell salvage is commonly used in surgeries that carry a major hemorrhagic risk to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation status after these types of surgeries, especially liver transplantation. There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population. The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.