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

April 11, 2013
December 26, 2013
April 2013
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01834690 on ClinicalTrials.gov Archive Site
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
Same as current
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.

Same as current
 
Uses of Immunosuppression Therapy in Patients With Liver Transplantation
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.

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.
Observational
Observational Model: Cohort
Not Provided
Retention:   None Retained
Description:

no biospecimens are to be retained

Non-Probability Sample

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

Evidence of Liver Transplantation
Not Provided
liver transplantation recipients
adult liver transplantation recipients (>=20 years at the date of surgery)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1088
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Chien-Ning Hsu, PhD (07)7317123 ext 6134
Taiwan
 
NCT01834690
102-0582C
No
Chien-Ning Hsu, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Chien-Ning Hsu, PhD Kaohsiung Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP