ImmunosuppressionNCT01137084
Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
A study testing solu medrol and a steroid-free immunosuppression protocol in people with Immunosuppression and Hepatocellular Carcinoma, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immunosuppression, Hepatocellular Carcinoma, Liver Transplantation
- What is being tested?
- solu medrol and a steroid-free immunosuppression protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
About this study
The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.
- Conditions
- Immunosuppression, Hepatocellular Carcinoma, Liver Transplantation, Post-operative Complications
- Being tested
- solu medrol, a steroid-free immunosuppression protocol
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solu medrolDrug
total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
a steroid-free immunosuppression protocolDrug
receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.
| Study group | Role | What they receive |
|---|---|---|
| a steroid immunosuppression protocol | Active comparator | Not described Receives: Drug: solu medrol |
| a steroid-free immunosuppression protocol | Active comparator | without steroid Receives: Drug: a steroid-free immunosuppression protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient and graft survival
patient and graft survival include surviral rate and recurrence-free survival rate
Measured: Over 12-month after liver transplantation
Secondary outcomes (1)
Postoperative complications
Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.
Measured: Over 12-month after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Nanchang University, First Affiliated Hospital of Zhejiang University, Shanghai Changzheng Hospital
- Investigators
- Zhi-Hai Peng, MD, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137084
- Sponsor's protocol ID
- 20100603
- Status last verified
- Jun 2010
- First submitted
- 3 Jun 2010
- Last updated
- 4 Jun 2010
- Results posted
- No
Publications
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.
PubMed 19857686Sutherland 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.
PubMed 19502970Li 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.
PubMed 19459814Mastrobuoni 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.
PubMed 17889125Humar 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.
PubMed 17645714
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
- ClinicalTrials.gov ID
- NCT01137084
- Acronym / sponsor ID
- 20100603
- Conditions
- Immunosuppression, Hepatocellular Carcinoma, Liver Transplantation, Post-operative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Nanchang University, First Affiliated Hospital of Zhejiang University, Shanghai Changzheng Hospital
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a steroid immunosuppression protocol | Active comparator | Drug: solu medrol |
| a steroid-free immunosuppression protocol | Active comparator | Drug: a steroid-free immunosuppression protocolwithout steroid |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solu medroltotal dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation | Drug | a steroid immunosuppression protocol |
| a steroid-free immunosuppression protocolreceive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids. | Drug | a steroid-free immunosuppression protocol |
Primary outcome
patient and graft survival
Time frame: Over 12-month after liver transplantation
patient and graft survival include surviral rate and recurrence-free survival rate
1 secondary outcome
Postoperative complications
Time frame: Over 12-month after liver transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
- Results publication: PubMed 19857686Foroncewicz 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 publication: PubMed 19502970Sutherland 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 publication: PubMed 19459814Li 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 publication: PubMed 17889125Mastrobuoni 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 publication: PubMed 17645714Humar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Hai Peng, MD study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing solu medrol and a steroid-free immunosuppression protocol in people with Immunosuppression and Hepatocellular Carcinoma, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient and graft survival (time frame: Over 12-month after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01137084, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.