Liver TransplantationPhase 4NCT03216447
A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant
A Phase 4 study testing Advagraf and Prograf in people with Liver Transplantation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Advagraf and Prograf
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Nov 2017to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan
Wei-Chen Lee, 03-3281200 ext. 3631
About this study
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.
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.
Read the 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)
- Conditions
- Liver Transplantation
- Being tested
- Advagraf, Prograf
- Keywords
- adherence, conversion, advagraf, prograf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
Tacrolimus prolonged-release hard capsules (QD)
PrografDrug
Tacolimus capsules (q12h)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Switch from Prograf to Advagraf on POD 15 Receives: Drug: Advagraf |
| Control Arm | Active comparator | Continue Prograf treatment Receives: Drug: Prograf |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Visit 1 (Day 14) to Visit 6 (Day 364) - 50 weeks observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start23 Nov 2017
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Principal investigator, Wei-Chen Lee, Chang Gung Memorial Hospital
- Investigators
- Wei-Chen Lee, Principal investigator, CGMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216447
- Sponsor's protocol ID
- 201600495A3
- Status last verified
- Jun 2020
- First submitted
- 10 Jul 2017
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03216447
- Acronym / sponsor ID
- 201600495A3
- Conditions
- Liver Transplantation
- Keywords
- adherence, conversion, advagraf, prograf
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: AdvagrafSwitch from Prograf to Advagraf on POD 15 |
| Control Arm | Active comparator | Drug: PrografContinue Prograf treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdvagrafTacrolimus prolonged-release hard capsules (QD) | Drug | Experimental Arm |
| PrografTacolimus capsules (q12h) | Drug | Control Arm |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Chen Lee principal investigator
CGMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Advagraf and Prograf in people with Liver Transplantation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Chen Lee (09753-68195, weichen@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.