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

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: Astellas Pharma Taiwan, Inc.
• Treatments: Immunosuppressive Agents; Tacrolimus

Criteria

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