University of Pennsylvania
Researchers are interested in determining whether it is safe to reduce anti-rejection medication by approximately 50% after liver transplantation and whether special blood tests called biomarkers can identify early signs that the body is starting to attack the new liver before it gets hurt.
To evaluate the clinical utility of a miRNA-based signature for detecting alloimmune activation and early liver injury, when used in conjunction with conventional biochemical monitoring, to guide calcineurin (CNI) immunosuppression minimization in stable liver transplant recipients transplanted for non-immune liver diseases at least one year after transplantation. This is a multicenter, prospective, open-label, randomized controlled trial in stable liver transplant recipients receiving a CNI-based immunosuppression regimen. Participants will undergo closely monitored immunosuppression minimiza…
Inclusion Criteria: * 1\. Age \>18 years old. 2. \>12 months and \< 24 months post transplantation. 3. Liver transplant for non-immune liver disease. 4. For participants with HCV (history of HCV or donor with history of HCV): must be HCV PCR negative and have documented history of Sustained Viral Response to antiviral therapy (\>=12 weeks) or documented, persistent spontaneous clearance of HCV. 5\. For participants with HBV: must be controlled with HBV antiviral treatment and anticipate receiving continuing HBV antiviral treatment for the duration of study participation. 6\. Receiving m…
Participants undergo calcineurin inhibitor (CNI) dose reduction with immunosuppression minimization guided by a miRNA-based biomarker in conjunction with conventional biochemical monitoring.
Participants undergo calcineurin inhibitor (CNI) dose reduction with immunosuppression minimization guided by conventional biochemical monitoring alone.
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