Liver TransplantationPhase 2toleranceNCT01198314
Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients
A Phase 2 study testing immunosuppression withdrawal and continue of taking immunosuppressant in people with Liver Transplantation, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Long-term immunosuppression carries potential adverse effects such as risk of infection, malignancy, renal insufficiency, diabetes and hypertension. In clinical liver transplantation, some liver transplant recipients maintain allograft function without immunosuppressive drugs. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- immunosuppression withdrawal and continue of taking immunosuppressant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Mar 2013
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- long term stable liver transplant recipients
Who cannot join
- liver transplant due to autoimmune disease
- liver transplant due to hepatitis C virus (HCV)
- history of graft rejection
- history of biliary infection or stricture
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul, 137-040
Jong Young Choi, Professor, 82-2-2258-2073, jychoi@catholic.ac.kr
About this study
Official title: Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance
Long-term immunosuppression carries potential adverse effects such as risk of infection, malignancy, renal insufficiency, diabetes and hypertension. In clinical liver transplantation, some liver transplant recipients maintain allograft function without immunosuppressive drugs. This is called as "operational tolerance". Many attempts have been made to identify immunological biomarkers predicting operational tolerant patients. Therefore, the investigators aimed to identify patients who have the potential to be operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop ultimately with monitoring of biomarkers.
Read the detailed description
Among long term stable liver transplant recipients, we will select some proportion of patients who have the high potential for obtaining operational tolerance using biomarkers.
Then, we will gradually reduce immunosuppressants and monitor biomarkers as well as biochemical tests. The course of tapering off immunosuppressant will take about 1 year.
During withdrawal of immunosuppression, participants will be closely monitored for liver enzyme, immunological profile.
If there are some signs of rejection, liver biopsy will be undertaken and participants will be treated using immunosuppressant.
After complete withdrawal of immunosuppressant, participants will be followed for at least of 1 year.
- Conditions
- Liver Transplantation
- Being tested
- immunosuppression withdrawal, continue of taking immunosuppressant
- Keywords
- long term, stable, recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunosuppression withdrawalProcedure or surgery
Also called WIS
tapering off immunosuppressant
continue of taking immunosuppressantProcedure or surgery
Also called MIS
maintain immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| LT, withdrawal of immunosuppression | Experimental | Not described Receives: Procedure: immunosuppression withdrawal |
| LT, maintenance of immunosuppression | Active comparator | Not described Receives: Procedure: continue of taking immunosuppressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants who have the potential for the operational tolerance
measure number of patients who can be weaned off immunosuppression completely
Measured: in the 2 years fololowing study enrollment
Secondary outcomes (2)
Tolerance biomarker
find out biomarkers which can predict operational tolerance
Measured: 1 year following immunosuppression withdrawal
immunologic profile related to rejection
observe immunologic profile changes which are related to rejection
Measured: up to 2 years following withdrawal of immunosuppression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Jong Young Choi, Professor, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198314
- Sponsor's protocol ID
- CMCLTIT
- Other IDs
- A092258-0911-1030100
- Acronym
- tolerance
- Status last verified
- Jul 2010
- First submitted
- 7 Sep 2010
- Last updated
- 10 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castellaneta A, Thomson AW, Nayyar N, de Vera M, Mazariegos GV. Monitoring the operationally tolerant liver allograft recipient. Curr Opin Organ Transplant. 2010 Feb;15(1):28-34. doi: 10.1097/MOT.0b013e328334269a.
PubMed 19890211
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance
- ClinicalTrials.gov ID
- NCT01198314
- Acronym / sponsor ID
- tolerance / CMCLTIT
- Conditions
- Liver Transplantation
- Keywords
- long term, stable, recipients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 10 Sep 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.
Long-term immunosuppression carries potential adverse effects such as risk of infection, malignancy, renal insufficiency, diabetes and hypertension. In clinical liver transplantation, some liver transplant recipients maintain allograft function without immunosuppressive drugs. This is called as "operational tolerance". Many attempts have been made to identify immunological biomarkers predicting operational tolerant patients. Therefore, the investigators aimed to identify patients who have the potential to be operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop ultimately with monitoring of biomarkers.
Detailed description
Among long term stable liver transplant recipients, we will select some proportion of patients who have the high potential for obtaining operational tolerance using biomarkers.
Then, we will gradually reduce immunosuppressants and monitor biomarkers as well as biochemical tests. The course of tapering off immunosuppressant will take about 1 year.
During withdrawal of immunosuppression, participants will be closely monitored for liver enzyme, immunological profile.
If there are some signs of rejection, liver biopsy will be undertaken and participants will be treated using immunosuppressant.
After complete withdrawal of immunosuppressant, participants will be followed for at least of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT, withdrawal of immunosuppression | Experimental | Procedure: immunosuppression withdrawal |
| LT, maintenance of immunosuppression | Active comparator | Procedure: continue of taking immunosuppressant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- long term stable liver transplant recipients
Key exclusion criteria (4 listed)
- liver transplant due to autoimmune disease
- liver transplant due to hepatitis C virus (HCV)
- history of graft rejection
- history of biliary infection or stricture
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 |
|---|---|---|
| immunosuppression withdrawalAlso: WIStapering off immunosuppressant | Procedure or surgery | LT, withdrawal of immunosuppression |
| continue of taking immunosuppressantAlso: MISmaintain immunosuppression | Procedure or surgery | LT, maintenance of immunosuppression |
Primary outcome
number of participants who have the potential for the operational tolerance
Time frame: in the 2 years fololowing study enrollment
measure number of patients who can be weaned off immunosuppression completely
2 secondary outcomes
Tolerance biomarker
Time frame: 1 year following immunosuppression withdrawal
immunologic profile related to rejection
Time frame: up to 2 years following withdrawal of immunosuppression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2010.
- Background: PubMed 19890211Castellaneta A, Thomson AW, Nayyar N, de Vera M, Mazariegos GV. Monitoring the operationally tolerant liver allograft recipient. Curr Opin Organ Transplant. 2010 Feb;15(1):28-34. doi: 10.1097/MOT.0b013e328334269a.
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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.
Jong Young Choi, Professor study chair
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing immunosuppression withdrawal and continue of taking immunosuppressant in people with Liver Transplantation, run by The Catholic University of Korea at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Sep 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Young Choi, Professor (82-2-2258-2073, jychoi@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants who have the potential for the operational tolerance (time frame: in the 2 years fololowing study enrollment). 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 NCT01198314, which also lists 1 linked publication.
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 10 Sep 2010.