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Completed

NCT Number: NCT01834690

Uses of Immunosuppression Therapy 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.

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Key information

Conditions

Evidence of Liver Transplantation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 18, 2013
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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