Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
NCT ID: NCT01137084
Last Updated: 2010-06-04
Study Results
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Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2005-01-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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a steroid immunosuppression protocol
solu medrol
total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
a steroid-free immunosuppression protocol
without steroid
a steroid-free immunosuppression protocol
receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.
Interventions
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solu medrol
total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
a steroid-free immunosuppression protocol
receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to provide written informed consent prior to study entry
* acute rejection are treated only with steroids
ALL
No
Sponsors
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First Affiliated Hospital of Fujian Medical University
OTHER
Nanchang University
OTHER
Zhejiang University
OTHER
Shanghai Changzheng Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Principal Investigators
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Zhi-Hai Peng, MD
Role: STUDY_CHAIR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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20100603
Identifier Type: -
Identifier Source: org_study_id
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