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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT05335551
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age.
* Recipient of a primary or subsequent deceased-donor or living donor liver transplantation.
* Normal liver function tests at the time of or within 2 weeks of the baseline visit, defined by Total Bilirubin (TB) ≤1.5 mg/dL and Direct Bilirubin (DB) \<0.5 mg/dL, Alkaline Phosphatase (AP) ≤200 U/L, and Alanine Transaminase (ALT) ≤60 U/L (males) ≤36 U/L (females).
* Between 1-2 months post-liver transplantation
Exclusion Criteria:
* Inability or unwillingness to provide informed consent.
* Recipients of previous hepatic or non-hepatic solid organ transplantation
* History of ≥2 mild or moderate rejections or 1 severe rejection prior to enrollment defined by BANFF 2016 criteria
* History of autoimmune liver disease
* Listed for repeat liver transplantation
* Infection with HIV
* Active HBV or HCV viremia (patients with undetectable virus can be included)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05335551
Study Brief:
Protocol Section:
NCT05335551