Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

This study has been completed.

Sponsor:

Collaborators:

First Affiliated Hospital of Fujian Medical University

Nanchang University

Zhejiang University

Shanghai Changzheng Hospital

Information provided by:

Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT01137084

First received: June 3, 2010

Last updated: NA

Last verified: June 2010

History: No changes posted

Purpose

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

Condition	Intervention
Immunosuppression Hepatocellular Carcinoma Liver Transplantation Post-operative Complications	Drug: solu medrol Drug: a steroid-free immunosuppression protocol

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:

patient and graft survival [ Time Frame: Over 12-month after liver transplantation ] [ Designated as safety issue: No ]
patient and graft survival include surviral rate and recurrence-free survival rate

Secondary Outcome Measures:

Postoperative complications [ Time Frame: Over 12-month after liver transplantation ] [ Designated as safety issue: Yes ]
Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.

Estimated Enrollment:	300
Study Start Date:	January 2005
Study Completion Date:	December 2009
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: a steroid immunosuppression protocol	Drug: solu medrol total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
Active Comparator: a steroid-free immunosuppression protocol without steroid	Drug: 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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137084

Locations

China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

First Affiliated Hospital of Fujian Medical University

Nanchang University

Zhejiang University

Shanghai Changzheng Hospital

Investigators

Study Chair:

Zhi-Hai Peng, MD

Shanghai First People's Hospital

More Information

Publications:

Foroncewicz B, Mucha K, Ryszkowska E, Ciszek M, Zió?kowski 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.

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. Erratum in: Transplantation. 2009 Sep 27;88(6):852.

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. 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.

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.

ClinicalTrials.gov Identifier:	NCT01137084 History of Changes
Other Study ID Numbers:	20100603
Study First Received:	June 3, 2010
Last Updated:	June 3, 2010
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Carcinoma
Postoperative Complications
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Methylprednisolone acetate
Prednisolone acetate

Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 16, 2013

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