drugset / Trial / NCT02081755
Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil/Azathioprine. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
Timeline
- Start
- 2014-03
- Primary completion
- 2027-03
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 0.5 mg/kg | — |
| Comparator | Azathioprine | Small molecule | 2 mg/kg | — |
| Subject | Everolimus | Small molecule | 1.5 mg | — |
| Comparator | Mycophenolate Mofetil | Small molecule | 500 mg | — |
| Comparator | Mycophenolate Mofetil | Small molecule | 1500 mg | — |
| Comparator | mycophenolic acid | Small molecule | 360 mg | — |
| Comparator | mycophenolic acid | Small molecule | 1080 mg | — |
| Background | Tacrolimus | Small molecule | 0.05 mg/kg | — |