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Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
Sponsor: Chiesi Hungary Ltd.
Summary
The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question\[s\] it aims to answer are: * Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C/D) * Changes in liver function parameters compared to baseline. * Change in the estimated glomerular filtration rate (eGFR) compared to baseline. * To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage) * Incidence of acute graft rejection during the study * Incidence of BK and cytomegalovirus (CMV) infection during the study * To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D) * To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record. Participants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care
Official title: Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
110
Start Date
2023-05-10
Completion Date
2026-06-01
Last Updated
2024-08-22
Healthy Volunteers
Not specified
Conditions
Interventions
Tacrolimus
Tacrolimus received as part of routine clinical care
Locations (2)
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
Budapest, Hungary
University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroenterology
Ljubljana, Slovenia