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Uses of Immunosuppression Therapy in Patients With Liver Transplantation

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ClinicalTrials.gov Identifier: NCT01834690
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Chien-Ning Hsu, Chang Gung Memorial Hospital

Brief 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, metabolic syndrome, cardiovascular disease, renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections after transplantation.

Condition or disease
Evidence of Liver Transplantation

Detailed Description:

Specific aims are proposed to achieve in this study:

  1. 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.
  2. 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
Observational Model: Cohort
Official Title: Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
liver transplantation recipients
adult liver transplantation recipients (>=20 years at the date of surgery)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. health-related quality of life [ Time Frame: 5 years ]
    health-related quality of life will be measured by EQ-5D-5L and 15D


Other Outcome Measures:
  1. 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
no biospecimens are to be retained


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study subjects: Patients who had liver transplantation in Kaohsiung Chang Gung Memorial Hospital
Criteria

Aim 1:

Inclusion Criteria:

  • age at liver transplantation is at least 20 years

Aim 2:

Inclusion Criteria:

  • age at liver transplantation is at least 20 years

Exclusion Criteria:

  • deceased patient
  • cannot obtain inform consent
  • age <20 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834690


Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chien-Ning Hsu, PhD Chang Gung Memorial Hospital

Responsible Party: Chien-Ning Hsu, Clinical Pharmacist, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01834690     History of Changes
Other Study ID Numbers: 102-0582C
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Keywords provided by Chien-Ning Hsu, Chang Gung Memorial Hospital:
Liver transplantation/epidemiology
Liver transplantation/pharmacology
Health status/drug effects
Agents, immunosuppressive agents

Additional relevant MeSH terms:
Liver Extracts
Hematinics