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

Phase 4

Recruiting

• Conditions: Liver Transplantation
• Interventions: Drug: Advagraf; Drug: Prograf

• Registration Number: NCT03216447
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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)

Study Timeline

• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Study Start: 2017-11-23
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-05
• Primary Completion: 2023-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Advagraf	Switch from Prograf to Advagraf on POD 15
Control Arm	Prograf	Continue Prograf treatment

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan