Evidence of Liver TransplantationNCT01834690
Uses of Immunosuppression Therapy in Patients With Liver Transplantation
An observational study of Evidence of Liver Transplantation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Conventionally, the outcome of liver transplantation is usually reported in terms of graft and patient survival, medical and surgical complications, but lack of health-related quality of life (HRQOL) that might be associated with immunosuppression complications (e.g., diabetes, hypertension, dyslipidemia, obesity… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Evidence of Liver Transplantation
- How many people
- 314 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Dec 2014
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects: Patients who had liver transplantation in Kaohsiung Chang Gung Memorial Hospital
Who may be able to join
- age at liver transplantation is at least 20 years
- Aim 2:
- age at liver transplantation is at least 20 years
Who cannot join
- deceased patient
- cannot obtain inform consent
- age <20 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation
Conventionally, the outcome of liver transplantation is usually reported in terms of graft and patient survival, medical and surgical complications, but lack of health-related quality of life (HRQOL) that might be associated with immunosuppression complications (e.g., diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease, renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections after transplantation.
Read the detailed description
Specific aims are proposed to achieve in this study:
- To compare graft and patient survival rate, incidence of treatment-related adverse effects between different patterns of immunosuppression combination among patients received post-liver transplant care in Kaohsiung Chang Gung Memorial Hospital (KCGMH), Taiwan.
- To quantify the long-term health impacts of immunosuppressive regimens on quality-adjusted life expectancy (QALE), the loss-of-QALE relating to immunosuppression therapy, and types of transplantation.
- Conditions
- Evidence of Liver Transplantation
- Keywords
- Liver transplantation/epidemiology, Liver transplantation/pharmacology, Health status/drug effects, Agents, immunosuppressive agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| liver transplantation recipients | adult liver transplantation recipients (>=20 years at the date of surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of graft and patient mortality, treatment-related complications
Patient will be followed from the date of liver transplantation to the occurence of outcome event for 5 years
Measured: 5 years
Secondary outcomes (1)
health-related quality of life
health-related quality of life will be measured by EQ-5D-5L and 15D
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Ning Hsu, Chang Gung Memorial Hospital
- Investigators
- Chien-Ning Hsu, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834690
- Sponsor's protocol ID
- 102-0582C
- Status last verified
- Feb 2015
- First submitted
- 11 Apr 2013
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation
- ClinicalTrials.gov ID
- NCT01834690
- Acronym / sponsor ID
- 102-0582C
- Conditions
- Evidence of Liver Transplantation
- Keywords
- Liver transplantation/epidemiology, Liver transplantation/pharmacology, Health status/drug effects, Agents, immunosuppressive agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Apr 2013 (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.
Conventionally, the outcome of liver transplantation is usually reported in terms of graft and patient survival, medical and surgical complications, but lack of health-related quality of life (HRQOL) that might be associated with immunosuppression complications (e.g., diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease, renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections after transplantation.
Detailed description
Specific aims are proposed to achieve in this study:
- To compare graft and patient survival rate, incidence of treatment-related adverse effects between different patterns of immunosuppression combination among patients received post-liver transplant care in Kaohsiung Chang Gung Memorial Hospital (KCGMH), Taiwan.
- To quantify the long-term health impacts of immunosuppressive regimens on quality-adjusted life expectancy (QALE), the loss-of-QALE relating to immunosuppression therapy, and types of transplantation.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver transplantation recipients | – | –adult liver transplantation recipients (>=20 years at the date of surgery) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects: Patients who had liver transplantation in Kaohsiung Chang Gung Memorial Hospital
Key inclusion criteria (3 listed)
- age at liver transplantation is at least 20 years
- age at liver transplantation is at least 20 years
Key exclusion criteria (3 listed)
- deceased patient
- cannot obtain inform consent
- age <20 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of graft and patient mortality, treatment-related complications
Time frame: 5 years
Patient will be followed from the date of liver transplantation to the occurence of outcome event for 5 years
1 secondary outcome
health-related quality of life
Time frame: 5 years
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 18 Feb 2015.
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.
Chien-Ning Hsu, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evidence of Liver Transplantation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 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 18 Feb 2015. 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 Taiwan. 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?
incidence of graft and patient mortality, treatment-related complications (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2015.