Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01807767
Eligibility Criteria:
Inclusion Criteria:
Patients must give written informed consent before any assessment is performed.
1. MELD ≥ 25.
2. Recipients who are 18-70 years of age of a primary or secondary liver transplant from a deceased donor.
3. Allograft is functioning at an acceptable level by the time of randomization as defined by the Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin levels ≤3 times Upper Limit of Normal (ULN), and Alkaline Phosphatase (AlkP) levels ≤ 5 times ULN.
4. Ability and willingness to provide written informed consent and adhere to study regimen.
5. Patients who are able to take oral medication at time of randomization. Glomerular Filtration Rate (GFR) ≥ 30 ml/min.
Exclusion Criteria:
1. Patients receiving 3rd transplants
2. Fulminant hepatic failure
3. Living donor transplants
4. Donation after Cardiac Death (DCD) donors or split grafts
5. Active infection or hemodynamic instability at the time of transplant
6. Renal replacement therapy for clearance within 7 days prior to randomization
7. Presence of thrombosis via Doppler ultrasound of the major hepatic arteries, major hepatic veins, portal vein and inferior vena cava.
8. An episode of acute rejection that required antibody therapy or more than one steroid sensitive episode of acute rejection prior to randomization. This includes patients who have not completed steroid treatment for acute rejection within 7 days prior to randomization.
9. Spot urine protein/creatinine ratio \> 1g/24h at time of randomization
10. Combined liver/kidney transplant
11. Patients who have severe hypercholesterolemia (\>350 mg/dL) or Patients with platelet count \< 50,000 at time of randomization
12. Patients with an Absolute neutrophil count (ANC) of \< 1,000 or White Blood Count (WBC) of \<2,000 at time of randomization
13. Patients with hemoglobin \<6g/dL
14. Patients who are unable to take oral medication at time of randomization
15. Patients with clinically significant systemic infection requiring active use of IV antibiotics, anti-virals, or anti-fungals
16. Patients who are in a critical care setting at the time of randomization requiring life support measures such as mechanical ventilation, dialysis, requirement of vasopressor agents
17. Known intolerance to tacrolimus or everolimus or Myfortic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01807767
Study Brief:
Protocol Section:
NCT01807767