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Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

Primary Purpose

Immunosuppression, Hepatocellular Carcinoma, Liver Transplantation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
solu medrol
a steroid-free immunosuppression protocol
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunosuppression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment

Exclusion Criteria:

  • the recipient pass away within 3 month following up liver transplantation
  • Inability to provide written informed consent prior to study entry
  • acute rejection are treated only with steroids

Sites / Locations

  • Shanghai First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

a steroid immunosuppression protocol

a steroid-free immunosuppression protocol

Arm Description

without steroid

Outcomes

Primary Outcome Measures

patient and graft survival
patient and graft survival include surviral rate and recurrence-free survival rate

Secondary Outcome Measures

Postoperative complications
Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.

Full Information

First Posted
June 3, 2010
Last Updated
June 3, 2010
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
First Affiliated Hospital of Fujian Medical University, Nanchang University, Zhejiang University, Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01137084
Brief Title
Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
First Affiliated Hospital of Fujian Medical University, Nanchang University, Zhejiang University, Shanghai Changzheng Hospital

4. Oversight

5. Study Description

Brief Summary
The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunosuppression, Hepatocellular Carcinoma, Liver Transplantation, Post-operative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
a steroid immunosuppression protocol
Arm Type
Active Comparator
Arm Title
a steroid-free immunosuppression protocol
Arm Type
Active Comparator
Arm Description
without steroid
Intervention Type
Drug
Intervention Name(s)
solu medrol
Intervention Description
total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
Intervention Type
Drug
Intervention Name(s)
a steroid-free immunosuppression protocol
Intervention Description
receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.
Primary Outcome Measure Information:
Title
patient and graft survival
Description
patient and graft survival include surviral rate and recurrence-free survival rate
Time Frame
Over 12-month after liver transplantation
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.
Time Frame
Over 12-month after liver transplantation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment Exclusion Criteria: the recipient pass away within 3 month following up liver transplantation Inability to provide written informed consent prior to study entry acute rejection are treated only with steroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Hai Peng, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19857686
Citation
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 Reference
result
PubMed Identifier
19502970
Citation
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. Erratum In: Transplantation. 2009 Sep 27;88(6):852.
Results Reference
result
PubMed Identifier
19459814
Citation
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 Reference
result
PubMed Identifier
17889125
Citation
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 Reference
result
PubMed Identifier
17645714
Citation
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.
Results Reference
result

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Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

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