Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01137084
Collaborator
First Affiliated Hospital of Fujian Medical University (Other), Nanchang University (Other), Zhejiang University (Other), Shanghai Changzheng Hospital (Other)
300
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2
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5.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Jan 1, 2005
Actual Primary Completion Date
:
Jan 1, 2008
Actual Study Completion Date
:
Dec 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- patient and graft survival [Over 12-month after liver transplantation]
patient and graft survival include surviral rate and recurrence-free survival rate
Secondary Outcome Measures
- Postoperative complications [Over 12-month after liver transplantation]
Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 General Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01137084
Other Study ID Numbers:
- 20100603
First Posted:
Jun 4, 2010
Last Update Posted:
Jun 4, 2010
Last Verified:
Jun 1, 2010