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CompletedNCT01834690Updated Feb 18, 2015

Uses of Immunosuppression Therapy in Patients With Liver Transplantation

An observational study in Evidence of Liver Transplantation, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-02-18.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Enrollment
314
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Evidence of Liver Transplantation

Keywords

  • Liver transplantation/epidemiology
  • Liver transplantation/pharmacology
  • Health status/drug effects
  • Agents, immunosuppressive agents
03

In context

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

Eligibility 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
05

Study design

Observational model
Cohort
Enrollment
314 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • liver transplantation recipients

    adult liver transplantation recipients (\>=20 years at the date of surgery)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

Secondary outcomes

  1. health-related quality of life

    health-related quality of life will be measured by EQ-5D-5L and 15D

    Time frame: 5 years

Other outcomes

  1. quality-adjusted life expectancy (QALE), loss-of-QALE

    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.

    Time frame: 5 years

07

Study locations

1 site
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung, 833, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01834690
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Chien-Ning Hsu (Clinical Pharmacist, Chang Gung Memorial Hospital) — Principal investigator
First posted
Apr 18, 2013
Start date
Apr 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Feb 18, 2015

Study contacts

Chien-Ning Hsu, PhD
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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