NCT01834690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

1.7 years

First QC Date

April 11, 2013

Last Update Submit

February 15, 2015

Conditions

Evidence of Liver Transplantation

Keywords

Liver transplantation/epidemiologyLiver transplantation/pharmacologyHealth status/drug effectsAgents, immunosuppressive agents

Outcome Measures

Primary Outcomes (1)

  • incidence of graft and patient mortality, treatment-related complications

    Patient will be followed from the date of liver transplantation to the occurence of outcome event for 5 years

    5 years

Secondary Outcomes (1)

  • health-related quality of life

    5 years

Other Outcomes (1)

  • quality-adjusted life expectancy (QALE), loss-of-QALE

    5 years

Study Arms (1)

liver transplantation recipients

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • age at liver transplantation is at least 20 years
  • Aim 2:
  • age at liver transplantation is at least 20 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Biospecimen

Retention: NONE RETAINED

no biospecimens are to be retained

Study Officials

  • Chien-Ning Hsu, PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 18, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

TW(1)