Status:
UNKNOWN
TRU-IMMUNO: Optimizing Liver Immunosuppression
Lead Sponsor:
Transplant Genomics, Inc.
Conditions:
Liver Transplant Rejection
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multi-center, randomized study. The primary objective is to evaluate the feasibility and utility of TruGraf/TRAC Liver testing used in addition to standard of care measures of l...
Detailed Description
This study will provide TruGraf Liver and TRAC liver tests to one group of transplant providers early after liver transplantation to clarify if the Trugraf Liver and TRAC Liver results can complement ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05335551
Start Date
May 1 2022
End Date
May 1 2023
Last Update
May 2 2022
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