Evaluation of the benefits of Administering immunosuppressive drugs as Single daily doses over the first Year after liver transplantatio

Phase 1

• Conditions: transplantation; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

• Registration Number: CTIS2023-506601-19-00
• Lead Sponsor: Centre Hospitalier Universitaire De Limoges

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified