Liver TransplantPhase 4NCT04069065
Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)
A Phase 4 study testing Conversion to Once-daily Tacrolimus in people with Liver Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Conversion to Once-daily Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2019to 8 Apr 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one year after liver transplantation
- Over 20 years old(male or female)
- Patient taking tacrolimus twice daily as a maintenance therapy
- Patients with Tacrolimus blood levels of 3-10 at screening
- Agreement with written informed consent
Who cannot join
- Previously transplanted another organs other than the liver or at the same time
- Diagnosed and clinically treated with acute rejection within the last 6 months
- Patients who have changed the method of administering concomitant immunosuppressants or steroids within the last month
- Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled]
- Patients who have positive HIV test result
- Severe systemic infection requiring treatment
Show all 14Show fewer
- At screening
- White blood cell count < 1,500/mm^3, or platelet < 50,000/mm^3, or Serum-C r> 2.0mg/dl
- Liver function test(T-bilirubin, aspartate aminotransferase, alanine aminotransferase)is over 3 times than upper normal limit
- Patients Taking HCV(hepatitis C virus) Therapeutic Drugs
- Pregnant women or nursing mothers
- Fertile women who not practice contraception with appropriate methods
- Participated in other trial within 4 weeks
- In investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Conversion to TacroBell SR Cap.(Once-Daily Tacrolimus) in Patients Undergoing Maintenance Therapy With Twice-Daily Tacrolimus After Liver Transplantation.
The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation.
Read the detailed description
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients who have undergone at least one year after liver transplantation and receive maintenance therapy with Twice-Daily Tacrolimus.
Enrolled subjects will take TacroBell slow-release cap.(Once-daily Tacrolimus) for 24 weeks and will conduct scheduled tests with four additional visits.
- Conditions
- Liver Transplant
- Being tested
- Conversion to Once-daily Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion to Once-daily TacrolimusDrug
Also called TacroBell slow-release cap.
- Orally, once-daily in the morning
- The first dose is converted to approximately 100% of the existing daily dose, taking into account the subject's blood concentration, after which the investigator check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~10ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| Conversion to Once-daily Tacrolimus | Experimental | Conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation Receives: Drug: Conversion to Once-daily Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite efficacy failure
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
Measured: until 24 weeks
Secondary outcomes (6)
Incidence of biopsy-confirmed acute rejection
episode of biopsy-confirmed acute rejection until 24weeks after conversion
Measured: until 24 weeks
Pathological results of acute rejection
acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0~9
Measured: until 24 weeks
Survival rate of transplanted organ
Measured: at 24 weeks
Survival rate of Patients
Measured: at 24 weeks
Serum-Cr, eGFR(estimated glomerular filtration rate)
eGFR using MDRD(Modification of Diet in Renal Disease) method
Measured: at 24 weeks
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
Measured: until 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start31 Jul 2019
- Primary completion22 Feb 2021 (estimated)
- Study completion8 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069065
- Sponsor's protocol ID
- B93_03LT1901
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 28 Aug 2019
- 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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Conversion to TacroBell SR Cap.(Once-Daily Tacrolimus) in Patients Undergoing Maintenance Therapy With Twice-Daily Tacrolimus After Liver Transplantation.
- ClinicalTrials.gov ID
- NCT04069065
- Acronym / sponsor ID
- B93_03LT1901
- Conditions
- Liver Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 22 Feb 2021 (estimated)
- Study completion
- 8 Apr 2021 (estimated)
- First posted
- 28 Aug 2019 (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.
The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation.
Detailed description
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients who have undergone at least one year after liver transplantation and receive maintenance therapy with Twice-Daily Tacrolimus.
Enrolled subjects will take TacroBell slow-release cap.(Once-daily Tacrolimus) for 24 weeks and will conduct scheduled tests with four additional visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conversion to Once-daily Tacrolimus | Experimental | Drug: Conversion to Once-daily TacrolimusConversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least one year after liver transplantation
- Over 20 years old(male or female)
- Patient taking tacrolimus twice daily as a maintenance therapy
- Patients with Tacrolimus blood levels of 3-10 at screening
- Agreement with written informed consent
Key exclusion criteria (14 listed)
- Previously transplanted another organs other than the liver or at the same time
- Diagnosed and clinically treated with acute rejection within the last 6 months
- Patients who have changed the method of administering concomitant immunosuppressants or steroids within the last month
- Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled]
- Patients who have positive HIV test result
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 |
|---|---|---|
| Conversion to Once-daily TacrolimusAlso: TacroBell slow-release cap.* Orally, once-daily in the morning * The first dose is converted to approximately 100% of the existing daily dose, taking into account the subject's blood concentration, after which the investigator check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~10ng/ml. | Drug | Conversion to Once-daily Tacrolimus |
Primary outcome
Incidence of composite efficacy failure
Time frame: until 24 weeks
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
6 secondary outcomes
Incidence of biopsy-confirmed acute rejection
Time frame: until 24 weeks
Pathological results of acute rejection
Time frame: until 24 weeks
Survival rate of transplanted organ
Time frame: at 24 weeks
Survival rate of Patients
Time frame: at 24 weeks
Serum-Cr, eGFR(estimated glomerular filtration rate)
Time frame: at 24 weeks
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
Time frame: until 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Conversion to Once-daily Tacrolimus in people with Liver Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 5 inclusion and 14 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 28 Aug 2019. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite efficacy failure (time frame: until 24 weeks). 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 28 Aug 2019.