drugset / Trial / NCT01137084
Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
Completed
300 enrolled
Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital of Fujian Medical University · collabNanchang University · collabShanghai Changzheng Hospital · collabZhejiang University · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.
Timeline
- Start
- 2005-01
- Primary completion
- 2008-01
- Completion
- 2009-12
Publications
- Results Foroncewicz B, Mucha K, Ryszkowska E, Ciszek M, Ziolkowski J, Porowski D, Krawczyk M, Paczek L. Safety and efficacy of steroid-free immunosuppression with tacrolimus and daclizumab in liver transplant recipients: 6-year follow-up in a single center. Transplant Proc. 2009 Oct;41(8):3103-6. doi: 10.1016/j.transproceed.2009.07.082.
- Results Sutherland S, Li L, Concepcion W, Salvatierra O, Sarwal MM. Steroid-free immunosuppression in pediatric renal transplantation: rationale for and [corrected] outcomes following conversion to steroid based therapy. Transplantation. 2009 Jun 15;87(11):1744-8. doi: 10.1097/TP.0b013e3181a5df60.
- Results Li L, Chang A, Naesens M, Kambham N, Waskerwitz J, Martin J, Wong C, Alexander S, Grimm P, Concepcion W, Salvatierra O, Sarwal MM. Steroid-free immunosuppression since 1999: 129 pediatric renal transplants with sustained graft and patient benefits. Am J Transplant. 2009 Jun;9(6):1362-72. doi: 10.1111/j.1600-6143.2009.02640.x. Epub 2009 May 13.
- Results Mastrobuoni S, Ubilla M, Cordero A, Herreros J, Rabago G. Two-dose daclizumab, tacrolimus, mycophenolate mofetil, and steroid-free regimen in de novo cardiac transplant recipients: early experience. Transplant Proc. 2007 Sep;39(7):2163-6. doi: 10.1016/j.transproceed.2007.06.073.
- Results Humar A, Crotteau S, Gruessner A, Kandaswamy R, Gruessner R, Payne W, Lake J. Steroid minimization in liver transplant recipients: impact on hepatitis C recurrence and post-transplant diabetes. Clin Transplant. 2007 Jul-Aug;21(4):526-31. doi: 10.1111/j.1399-0012.2007.00683.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Basiliximab | Monoclonal antibody | 20 mg | — |
| Comparator | Methylprednisolone | Other / unclassified | 20 mg/kg | — |
| Comparator | Tacrolimus | Small molecule | 0.06 unknown | — |