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Evaluation of the benefits of Administering immunosuppressive drugs as Single daily doses over the first Year after liver transplantation
EU CTIS ID: 2023-506601-19-00
What this study is testing
1- To demonstrate, in liver transplant recipients on ENVARSUS®, that an immunosuppressive strategy based on MMF QD started at M6 post-transplantation is not inferior to MMF administered BID, in terms of incidence of treatment failure (defined by a composite endpoint) at M18 after transplantation 2- To demonstrate, in liver transplant recipients, that LCP-tacrolimus (ENVARSUS®) is equivalent to XR-tacrolimus (ADVAGRAF®) QD, in terms of incidence of treatment failure (defined by a composite endpoint) at the end of sixth month after transplantation
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.