Evaluation of Neurotrophin Mimetic Compound in Modulating Ischemia/Reperfusion Injury in Liver Transplantation with Extended Criteria Donors: A Phase I/II Study

The primary objective of this study is to evaluate the efficacy of a **neurotrophins mimetic compound** in modulating ischemia/reperfusion damage during **liver transplant** procedures involving extended criteria donors. This is clinically relevant as it aims to improve transplant outcomes by potentially reducing tissue damage and enhancing graft survival, which is critical in the context of liver transplantation where donor organ quality is a significant concern.

The clinical trial involves participants diagnosed with **Liver Transplant**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been specified. The trial aims to gather data from a diverse group of individuals without targeting any specific vulnerable groups.

The clinical trial is designed as a **randomized**, open-label, controlled study aimed at exploring the effects of a neurotrophin mimetic compound on ischemia/reperfusion damage in the context of **liver transplant** using extended criteria donors. The trial is categorized as a phase I/II study, with an estimated recruitment start date of January 8, 2024, and an anticipated completion date of July 31, 2025. The trial will involve a series of study visits, beginning with an inclusion visit where participants will be screened for eligibility based on predefined criteria. This initial visit will ensure that only suitable candidates are enrolled in the study.

Following the inclusion visit, participants will undergo a series of follow-up visits at specified intervals to monitor their response to the treatment and assess any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The sequence and frequency of these visits will be determined by the study protocol, ensuring comprehensive monitoring of each participant's progress. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the intervention.

The expected duration of participant involvement in the trial will be aligned with the study's timeline, from the initial screening to the end-of-study visit. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial's methodology and design are structured to ensure the collection of robust and reliable data, contributing to the understanding of the intervention's efficacy and safety in the context of liver transplantation.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a paediatric formulation or if it has orphan drug status. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available in the provided data.

The clinical trial is scheduled to commence recruitment on January 8, 2024, with an estimated completion date of July 31, 2025. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Efficacy assessments will be conducted at predetermined intervals throughout the trial duration. The specific parameters or endpoints for evaluating efficacy, as well as the methods and tools for measurement, collection, and analysis, are not detailed in the provided data. The trial's design and execution will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy outcomes.