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

Liver Transplantation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03216447
• Other study ID #: 201600495A3
• Status: Recruiting
• Phase: Phase 4
• Start date: November 23, 2017
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2020
• Source: Chang Gung Memorial Hospital
• Contact: Wei-Chen Lee
• Phone: 09753-68195
• Email: weichen[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2025
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Advagraf
Tacrolimus prolonged-release hard capsules (QD)
• Prograf
Tacolimus capsules (q12h)

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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