Uses of Immunosuppression Therapy in Patients With Liver Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chien-Ning Hsu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01834690
First received: April 11, 2013
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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
Evidence of Liver Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • incidence of graft and patient mortality, treatment-related complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Patient will be followed from the date of liver transplantation to the occurence of outcome event for 5 years


Secondary Outcome Measures:
  • health-related quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    health-related quality of life will be measured by EQ-5D-5L and 15D


Other Outcome Measures:
  • quality-adjusted life expectancy (QALE), loss-of-QALE [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 1088
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
liver transplantation recipients
adult liver transplantation recipients (>=20 years at the date of surgery)

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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834690

Contacts
Contact: Chien-Ning Hsu, PhD (07)7317123 ext 6134

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

No publications provided

Responsible Party: Chien-Ning Hsu, Clinical Pharmacist, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01834690     History of Changes
Other Study ID Numbers: 102-0582C
Study First Received: April 11, 2013
Last Updated: December 26, 2013
Health Authority: Taiwan : Food and Drug Administration

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

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014