Uses of Immunosuppression Therapy in Patients With Liver Transplantation

NCT ID: NCT01834690

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 314 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Evidence of Liver Transplantation

Study Design

• Observational Model Type: COHORT

Study Groups

liver transplantation recipients

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• age at liver transplantation is at least 20 years

Aim 2:

• age at liver transplantation is at least 20 years

Exclusion Criteria

• deceased patient
• cannot obtain inform consent
• age <20 years

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chien-Ning Hsu

Clinical Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chien-Ning Hsu, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

102-0582C

Identifier Type: -

Identifier Source: org_study_id