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

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ClinicalTrials.gov Identifier: NCT03216447
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Wei-Chen Lee, 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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Advagraf Drug: Prograf Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: open labeled
Primary Purpose: Treatment
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.
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Experimental Arm
Switch from Prograf to Advagraf on POD 15
Drug: Advagraf
Tacrolimus prolonged-release hard capsules (QD)

Active Comparator: Control Arm
Continue Prograf treatment
Drug: Prograf
Tacolimus capsules (q12h)




Primary Outcome Measures :
  1. Adherence of administration of Advagraf in newly Taiwanese (Chinese) liver transplant patients. [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216447


Contacts
Contact: Wei-Chen Lee 09753-68195 weichen@cgmh.org.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan
Contact: Wei-Chen Lee    03-3281200 ext 3631      
Sponsors and Collaborators
Chang Gung Memorial Hospital
Astellas Pharma Taiwan, Inc.
Investigators
Principal Investigator: Wei-Chen Lee CGMH

Responsible Party: Wei-Chen Lee, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03216447     History of Changes
Other Study ID Numbers: 201600495A3
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wei-Chen Lee, Chang Gung Memorial Hospital:
adherence
conversion
advagraf
prograf

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action