Uses of Immunosuppression Therapy in Patients With Liver Transplantation

Completed

• Conditions: Evidence of Liver Transplantation

• Registration Number: NCT01834690
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-18
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-15
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of graft and patient mortality, treatment-related complications	5 years	Patient will be followed from the date of liver transplantation to the occurence of outcome event for 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan