Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)

Launched by UNIVERSITY HOSPITAL, LIMOGES · Apr 3, 2024

Keywords

ClinConnect Summary

The EASY trial is studying whether giving liver transplant patients their immunosuppressive medications as a single daily dose instead of twice daily can improve their health and make it easier for them to stick to their medication schedule. Immunosuppressive drugs are crucial for preventing the body from rejecting the new liver, but many patients struggle to take them consistently, which can lead to serious health issues. The trial will compare two different regimens: one group will take a once-daily version of a common medication, while another group will continue with the traditional twice-daily dosing.

To participate in this trial, individuals need to be adults who have received their first liver transplant from a deceased donor within the last four weeks. They should not have any major health issues that could affect their transplant or the study. Participants can expect to be monitored closely, and their quality of life, as well as how well they stick to their medication plan, will be assessed throughout the year. This study aims to find a simpler, more effective way to help liver transplant patients manage their medications and improve their overall well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Recipients of a first liver allograft from a deceased donor
• • Transplanted for less than four weeks at enrolment.
• • Without inter-current progressive life-threatening or graft-threatening disease.
• • Having signed a written informed consent for their participation in the study.
• • Affiliated to, or beneficiary of, a social security regimen
• Exclusion Criteria:
• • Recipients of a split-liver transplantation.
• • Recipients of any transplanted organ other than the liver
• • Patient who has undergone colon resection
• • Patients under legal protection (guardianship, curatorship).
• • Patient presenting any contra-indication to tacrolimus or to MMF according to the summary of product characteristics (SmPC) of ENVARSUS®, ADVAGRAF® and CELLCEPT®.
• • Patients in whom everolimus-based calcineurin inhibitors (CNI) minimization is anticipated
• • Patients treated with HIV or HCV protease inhibitors.
• • Pregnant or lactating women.
• • Women of childbearing potential without any effective contraceptive method (according to the guidelines of CTFG, Clinical Trial Facilitation Group, related to contraception and pregnancy test in clinical trials) or not practicing sexual abstinence.
• • Sexually active men having a female partner, without any effective contraception.
• • Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.
• • Patients already enrolled in another clinical study evaluating drugs or therapeutic strategies.