Liver DiseasesPhase 2BRITRENCT07862439
Biomarker-guided Reduction of Immunosuppression in Liver Transplant Recipients (BRITRE)
A Phase 2 study testing miRNA Biomarker-Guided Immunosuppression Minimization and Conventional Biochemical Monitoring-Guided Immunosuppression Minimization in people with Liver Diseases, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- miRNA Biomarker-Guided Immunosuppression Minimization and Conventional Biochemical Monitoring-Guided Immunosuppression Minimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old.
- >12 months and < 24 months post transplantation.
- Liver transplant for non-immune liver disease.
- 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.
- For participants with HBV: must be controlled with HBV antiviral treatment and anticipate receiving continuing HBV antiviral treatment for the duration of study participation.
- Receiving maintenance IS with a CNI (tacrolimus, cyclosporin).
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- No history of BPAR in the prior 6 months.
- Stable immunosuppression for the prior 3 months.
- No history of chronic rejection.
- No known clinical history of cirrhosis post-transplant.
- Liver chemistry tests: total bilirubin, ALT, AST, GGT, and alkaline phosphatase all <= ULN for the prior 3 months.
- Stable renal function, with eGFR >= 30 ml/min/1.73m2 by CKD-EPI (2021).
- For participants known to have a history of TB or latent TB infection, documented history of completing appropriate treatment.
- Participants of childbearing potential must have a negative pregnancy test upon study entry.
- All participants with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study (http://www.fda.gov/birthcontrol).
- Vaccines up to date as per DAIT guidance for patients in interventional transplant trials of investigational immunosuppression.
Who cannot join
- Inability or unwillingness of a participant to give documented informed consent or comply with the study protocol.
- History of retransplantation or multi-organ transplantation.
- Split liver transplantation, except when involving a right tri-segment.
- Liver transplantation indication of autoimmune disease.
- Use of mTOR inhibitor during the prior 3 months.
- Any post-transplant diagnosis of malignancy (except basal cell carcinoma of skin) or recurrent hepatocellular carcinoma.
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- Active, uncontrolled systemic infection at enrollment.
- Known history of infection with human immunodeficiency virus (HIV).
- Pregnancy, breastfeeding, or plans to become pregnant during the study period.
- History of mental illness or substance abuse that could impact study compliance, as judged by the investigator.
- Any past or current medical history, physical examination findings, or laboratory test results not specified above, which, in the opinion of the investigator, may present additional risks, hinder compliance, or affect data quality or interpretation for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tracia Debnam, MS contact
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Miranda Targum, MHCI, 215-217-7054, miranda.targum@pennmedicine.upenn.edu
About this study
Official title: Biomarker-guided Reduction of Immunosuppression in Liver Transplant Recipients (BRITRE): A PHASE II TRIAL TO ASSESS THE SAFETY OF BIOMARKER GUIDED IMMUNOSUPPRESSION MINIMIZATION IN LIVER TRANSPLANT RECIPIENTS
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.
Read the detailed description
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 minimization with a target reduction of the CNI dose to 50% of the baseline maintenance dose.
Participants will be randomized in a 1:1 ratio to one of two immunosuppression minimization strategies: (1) guidance by a miRNA-based biomarker in conjunction with conventional biochemical monitoring, or (2) guidance by conventional biochemical monitoring alone.
- Conditions
- Liver Diseases
- Being tested
- miRNA Biomarker-Guided Immunosuppression Minimization, Conventional Biochemical Monitoring-Guided Immunosuppression Minimization
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNA Biomarker-Guided Immunosuppression MinimizationOther
Participants undergo calcineurin inhibitor (CNI) dose reduction with immunosuppression minimization guided by a miRNA-based biomarker in conjunction with conventional biochemical monitoring.
Conventional Biochemical Monitoring-Guided Immunosuppression MinimizationOther
Participants undergo calcineurin inhibitor (CNI) dose reduction with immunosuppression minimization guided by conventional biochemical monitoring alone.
| Study group | Role | What they receive |
|---|---|---|
| miRNA Biomarker-Guided Immunosuppression Minimization | Experimental | Participants undergo CNI dose reduction with immunosuppression minimization guided by a miRNA-based biomarker in conjunction with conventional biochemical monitoring. Receives: Other: miRNA Biomarker-Guided Immunosuppression Minimization |
| Conventional Biochemical Monitoring-Guided Immunosuppression Minimization | Active comparator | Participants undergo CNI dose reduction with immunosuppression minimization guided by conventional biochemical monitoring alone. Receives: Other: Conventional Biochemical Monitoring-Guided Immunosuppression Minimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful 50% Immunosuppressive CNI reduction
Successful 50% Immunosuppressive CNI reduction: Successful timepoint. protocol-directed 50% immunosuppression (IS) reduction up to the 12 month (~52 week).
Measured: Up to 12months
Allograft status: Rejection/graft loss
Allograft status: Rejection/graft loss: Freedom from Rejection/graft loss for 12 months (~52 weeks) after study enrollment.
This endpoint will be the time to first occurrence of any of the following allograft (rejection or organ failure) events:
- Biopsy-proven acute rejection (BPAR)
- Clinical rejection (rejection treatment administered in the absence of BPAR)
- Death or graft loss
Measured: 12 months after study enrollment
Secondary outcomes (2)
Decrease or improvement in renal function
Decrease or improvement in renal function defined as: (baseline eGFR) - (eGFR at 1-year post-randomization).
Measured: 1 year post randomization
For those with a baseline eGFR 30-90 mL/min/1.73 m2: absence of a 10% or greater decrease in eGFR
- For those with a baseline eGFR 30-90 mL/min/1.73 m2: absence of a 10% or greater decrease in eGFR
Measured: 1 year post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abraham Shaked, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862439
- Sponsor's protocol ID
- 26-7952
- Acronym
- BRITRE
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided