EVR and EPO for Liver Transplant Tolerance
This study is testing the safety of using two medications, Everolimus (EVR) and epoetin alfa (EPO), in adult liver transplant recipients. The goal is to help your body accept the new liver without needing as many anti-rejection medications over time. You could be eligible if you are 18 or older, had a liver transplant 1 to 10 years ago, and are currently taking tacrolimus (an anti-rejection medicine). The study will look at how many participants avoid infections, new cancers, and serious side effects after reducing their anti-rejection medicines. The current status of the study is unclear, and it plans to enroll 20 participants.
- Study design
- This is an open-label, single-arm study, meaning everyone receives the study treatments and both you and the study team will know which treatments you are getting. It is a Phase 1b study and plans to include 20 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 52 weeks after their anti-rejection medications are reduced.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
EVR and EPO for Liver Transplant Tolerance
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Sandy Feng, MD, PhD · STUDY_CHAIR · University of California, San Francisco
- Paolo Cravedi, M.D., Ph.D. · STUDY_CHAIR · Icahn School of Medicine at Mount Sinai: Transplantation
Who to contact
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What this trial measures
- The proportion of subjects free of opportunistic infection attributed to the investigational study regimenAt 52 weeks post-immunosuppression withdrawal (ISW)
The primary analysis will be performed using the Intention-to-Treat (ITT) and Per-Protocol (PP) analysis populations, and the proportion will be summarized with a point estimate and a two-sided, 95% confidence interval (CI) calculated using the Clopper-Pearson (exact) method
- The proportion of subjects free of malignancy attributed to the investigational study regimenAt 52 weeks post-immunosuppression withdrawal (ISW)
The primary analysis will be performed using the Intention-to-Treat (ITT) and Per-Protocol (PP) analysis populations, and the proportion will be summarized with a point estimate and a two-sided, 95% confidence interval (CI) calculated using the Clopper-Pearson (exact) method
- The proportion of subjects free of serious adverse events (SAEs) attributed to the investigational study regimenAt 52 weeks post-immunosuppression withdrawal (ISW)
The primary analysis will be performed using the Intention-to-Treat (ITT) and Per-Protocol (PP) analysis populations, and the proportion will be summarized with a point estimate and a two-sided, 95% confidence interval (CI) calculated using the Clopper-Pearson (exact) method