Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT02909335
Eligibility Criteria:
Pre-transplantation Inclusion Criteria:
* Adults (≥18 years), male or female,
* Patients due to receive a first liver transplant with a full or reduced graft taken from a donor brain-dead beating heart or a related living donor,
* Patients having given a free and informed written consent .
Post-transplantation Inclusion criteria: Patients meeting the following criteria will be included:
* Receiving basiliximab (Simulect)
* Whose immunosuppression regimen from day 5 could immediately consist of either tacrolimus or everolimus, in combination with mycophenolate mofetil and low dose corticosteroids
* With hepatic artery permeable to echo Doppler 4 days after transplant.
Exclusion Criteria:
* History of immunosuppressive therapy,
* Known hypersensitivity to the treatments or macrolides,
* HIV infection
* Autoimmune hepatitis,
* Primary sclerosing cholangitis,
* Programming or realization of a combined transplant,
* Pregnancy or lack of effective contraception,
* Breastfeeding.
* Incompatibility with the donor,
* Thrombosis of the hepatic artery between D0 and D4,
* Non-primary graft function leading to a re-registration on the waiting list.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02909335
Study Brief:
Protocol Section:
NCT02909335