A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant
NCT ID: NCT03216447
Last Updated: 2020-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2017-11-23
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Arm
Switch from Prograf to Advagraf on POD 15
Advagraf
Tacrolimus prolonged-release hard capsules (QD)
Control Arm
Continue Prograf treatment
Prograf
Tacolimus capsules (q12h)
Interventions
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Advagraf
Tacrolimus prolonged-release hard capsules (QD)
Prograf
Tacolimus capsules (q12h)
Eligibility Criteria
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Inclusion Criteria
* Patient is a primary liver transplant recipient
* Patient is 20 to 70 years of age
* Patient should be clearly conscious, fully understand and able to answer questionnaire
Exclusion Criteria
* Patient currently requires dialysis
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Patient has received a liver transplant from a non-heart beating donor
* Patient who is HCV negative has received an HCV positive (HCV RNA by PCR or HCV antibody) donor liver
* Patient who is HbsAg negative has received an HbsAg positive (HBV DNA by PCR or HBV antibody) donor liver
* Patient has received a liver transplant from a decrease donor \> 70 years of age
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully.
* Patient is hemodynamically unstable on POD 15
18 Years
70 Years
ALL
No
Sponsors
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Astellas Pharma Taiwan, Inc.
INDUSTRY
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Wei-Chen Lee
Professor
Principal Investigators
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Wei-Chen Lee
Role: PRINCIPAL_INVESTIGATOR
CGMH
Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Wei-Chen Lee
Role: primary
Other Identifiers
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201600495A3
Identifier Type: -
Identifier Source: org_study_id
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