Status:
ENROLLING_BY_INVITATION
TruGraf Liver Gene Expression Serial Test
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Transplant Genomics, Inc.
Conditions:
Autoimmune Liver Disease
Autoimmune Hepatitis
Eligibility:
All Genders
18+ years
Brief Summary
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) mon...
Detailed Description
Study Abstract Following liver transplantation, organ recipients require long-term immunosuppression therapy along with frequent surveillance of the transplanted graft for indications of rejection, in...
Eligibility Criteria
Inclusion
- Recipients ≥18 years of age
- Currently waitlisted for liver transplant or recipient of liver transplant within the last 30 days
- Primary indication for transplant due to autoimmune hepatitis (AIH) - Primary Biliary Cirrhosis (PBC) or Primary Sclerosing Cholangitis (PSC) etiologies
- First time, single-organ liver transplant recipient
- Willing and able to undergo protocol required TruGraf serial blood draws
Exclusion
- Recipient \<18 years of age
- Recipients of multi-organ or repeat transplantation
- Grafts from donors with HIV
- Grafts from donors with viremic Hepatitis A, B, C
- Inability to meet study requirements
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06061341
Start Date
August 1 2024
End Date
December 1 2026
Last Update
August 26 2025
Active Locations (2)
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1
Washington University and Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110