Uses of Immunosuppression Therapy in Patients With Liver Transplantation

February 15, 2015 updated by: Chien-Ning Hsu, Chang Gung Memorial Hospital

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study subjects: Patients who had liver transplantation in Kaohsiung Chang Gung Memorial Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health-related quality of life
Time Frame: 5 years
health-related quality of life will be measured by EQ-5D-5L and 15D
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chien-Ning Hsu, PhD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (ESTIMATE)

April 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 15, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 102-0582C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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