Uses of Immunosuppression Therapy in Patients With Liver Transplantation
|ClinicalTrials.gov Identifier: NCT01834690|
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : February 18, 2015
|Condition or disease|
|Evidence of Liver Transplantation|
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 Type :||Observational|
|Actual Enrollment :||314 participants|
|Official Title:||Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation|
|Study Start Date :||April 2013|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
liver transplantation recipients
adult liver transplantation recipients (>=20 years at the date of surgery)
- 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
- health-related quality of life [ Time Frame: 5 years ]health-related quality of life will be measured by EQ-5D-5L and 15D
- quality-adjusted life expectancy (QALE), loss-of-QALE [ Time Frame: 5 years ]
QALE:quality-adjusted weight for each health status (measured by EQ-5D)will be multiplied by the survival time and then summed to calculate the number of QALE.
Loss-of QALE: the life time expectancy (survival function) for thes study cohort will be compared with Taiwan general population of subjects who are age- and gender-matched with study subjects.
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834690
|Kaohsiung Chang Gung Memorial Hospital|
|Kaohsiung, Taiwan, 833|
|Principal Investigator:||Chien-Ning Hsu, PhD||Chang Gung Memorial Hospital|