Evaluation of the benefits of Administering immunosuppressive drugs as Single daily doses over the first Year after liver transplantation - 87RI23_0031

Centre Hospitalier Universitaire De Limoges0 个研究点目标入组 200 人开始时间: 2024年2月7日最近更新: 2024年8月21日

适应症

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•1.Male and female patients, aged 18 and older, 2.Recipients of a first liver allograft from a deceased donor, 3.Transplanted for less than four weeks at enrolment, 4.Without inter-current progressive life-threatening or graft-threatening disease, 5.Having signed a written informed consent for their participation in the study., 6.Affiliated to, or beneficiary of, a social security regimen

•1.Recipients of a split-liver transplantation, 9.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 during treatment by CELLCEPT and for 6 weeks after the end of CELLCEPT administration, 10.Sexually active men or their female partner without any effective contraception during treatment by CELLCEPT and for at least 90 days after the end of CELLCEPT administration, 6.Patients treated with HIV or HCV protease inhibitors, 11.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., 12.Patients already enrolled in another clinical study evaluating drugs or therapeutic strategies., 2.Recipients of any transplanted organ other than the liver, 3.Patient who has undergone colon resection, 4.Patients under legal protection (guardianship, curatorship), 5.Patient presenting any contra-indication to tacrolimus or to MMF according to the summary of product characteristics (SmPC) of ENVARSUS®, ADVAGRAF® and CELLCEPT®., 7.Patients in whom everolimus-based CNI minimization is anticipated, 8.Pregnant or lactating women without efficient contraceptive method (based on declaration)

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