A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant

Study Overview
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Brief Summary
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A study of patient adherence and convenience to immunosuppressive agents in newly liver transplant recipients - a prospective, multi-center, open-labeled, randomized clinical trial for comparison between once-daily early conversion and twice-daily tacrolimus formulation.

Detailed Description
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This is prospective, multi-center, open-labeled, randomized study to investigate adherence of administration of once-daily tacrolimus formulation (Advagraf®) in newly Taiwanese (Chinese) liver transplant patients. The procedure of liver transplantation will follow the site-specific procedure. Each subject will be randomized on postoperative day 15 (POD15; defined Day 14 +/- 1)

Official Title
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A Prospective, Multi-center, Open-labeled, Randomized Clinical Trial of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant Recipients to Compare QD Early Conversion and BID Tacrolimus Formulation.

Conditions
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Liver Transplantation

Intervention / Treatment
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* Drug: Advagraf
* Drug: Prograf


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been fully informed and has signed an IRB approved informed consent form within 7 days (Day 7-13) prior to POD 15 and is willing and able to follow study procedure 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 has previously received or is receiving an organ transplant other than a liver. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Switch from Prograf to Advagraf on POD 15 | Drug: Advagraf<br>* Tacrolimus prolonged-release hard capsules (QD)<br>|
| Active Comparator: Control Arm<br>Continue Prograf treatment | Drug: Prograf<br>* Tacolimus capsules (q12h)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence of administration of Advagraf in newly Taiwanese (Chinese) liver transplant patients. | • The adherence of enrolled 150 subjects will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS) | Visit 1 (Day 14) to Visit 6 (Day 364) - 50 weeks observation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, conversion, advagraf, prograf