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

NCT03216447 | Unknown Phase 4

• 1 other identifier: 201600495A3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

adherence; conversion; advagraf; prograf

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Switch from Prograf to Advagraf on POD 15

Drug: Advagraf

Control Arm

ACTIVE COMPARATOR

Continue Prograf treatment

Drug: Prograf

Interventions

Advagraf DRUG

Tacrolimus prolonged-release hard capsules (QD)

Experimental Arm

Prograf DRUG

Tacolimus capsules (q12h)

Control Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Astellas Pharma Taiwan, Inc.: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Wei-Chen Lee

  CGMH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Chen Lee

CONTACT

09753-68195; weichen@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open labeled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: November 23, 2017
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2025
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

TW (1)