Liver TransplantPhase 4STELLANCT04867720
Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients
A Phase 4 study testing Everolimus in people with Liver Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus 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?
- Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2021to 22 Feb 2023
- 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
- Patients who had liver transplantation from living donor and had passed over 3 months since operation.
- Over 20 years old
- Patients who are being treated with Tacrolimus at screening visit
- Patients who agreed to written informed consent
Who cannot join
- Patients who had received non-liver organs before liver transplantation or had received other organs while receiving liver.
- Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver
- Patients who have been diagnosed with acute rejection within 6 months and have been treated
- Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months
- Patients who have been diagnosed with malignant tumor within 5 years(however, the following will be excepted)
- fully recovered from skin cancer(squamous cell/basal cell carcinoma or thyroid cancer)
Show all 22Show fewer
- haptocellular carcinoma without main vessel invasion
- Patients with severe systemic infection
- Patients who are difficult to communicate due to mental disorder
- Patients who are in treatment for hapatitis, or are over 3 times higher than upper normal limit in liver function test(T-bilirubin, AST, ALT) or over 5 times higher than normal limit of ALP
- Patients who are(at screening visit)
- WBC<1,500/mm^3
- PLT<30,000/mm^3
- over 1.0 in Protein/creatinine ratio(UA test)
- eGFR<30mL/min/1.73m^2(MDRD)
- Total Cholesterol>350mg/dL or Triglycerides>500mg/dL
- Patients taking HCV(hapatitis C virus) therapeutic drug or anti-HCV positive patients who have positive result in HCV RNA test at screening visit
- Patients who had plasmapheresis within 1 week
- Those who are pregnant, nursing, or are not practicing contraception with appropriate method
- Patients who had plasmapheresis within 3 months
- if participated in other trail within 4 weeks(28 days)
- In investigator's judgement
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hosipital
Seoul
Kyung-Suk Suh, M.D.,Ph.D., 82-2-2072 7200, kssuh@snu.ac.kr
About this study
Official title: Multi-center, Single Arm, Open-label, Phase 4 STudy to Evaluate the Efficacy and Safety of CertiroBELL® Tablet Plus TAcrolimus in Primary Living Donor Liver Transplant Recipients
To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus
Read the detailed description
This study is multi-center, single arm, open-label, phase 4 study to evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus in primary living donor liver transplant recipients.
- Conditions
- Liver Transplant
- Being tested
- Everolimus
- Keywords
- Everolimus, CertiroBell, Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called CertiroBell Tab.
- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8mg/mL.
| Study group | Role | What they receive |
|---|---|---|
| CertiroBell Tablet | Experimental | Use in combination with Tacrolimus at least 6 months after liver transplantation. Receives: Drug: Everolimus |
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 after taking medicine
Secondary outcomes (8)
Incidence of biopsy-confirmed acute rejection
acute rejection confirmed by result of biopsy(over 4 points of RAI score)
Measured: until 24 weeks after taking medicine
Pathological result, time of occurrence, treatment method and treatment result of acute rejection confirmed by biopsy(over 4 points of RAI score)
details of acute rejection confiremd by result of biopsy(over 4 points of RAI score)
Measured: until 24 weeks after taking medicine
Survival rate of patients
Survival rate of patients
Measured: until 24 weeks after taking medicine
Survival rate of transplanted organ
Survival rate of transplanted organ
Measured: until 24 weeks after taking medicine
Incidence rate of liver cancer
Incidence rate of liver cancer
Measured: until 24 weeks after taking medicine
Recurrence rate of liver cancer
Recurrence rate of liver cancer
Measured: until 24 weeks after taking medicine
Incidence rate of CMV infection
Incidence rate of CMV infection
Measured: until 24 weeks after taking medicine
Variation of serum creatinine, eGFR(estimated glomerular filtration rate) compared to baseline using MDRD(Modification of Diet in Renal Disease)
eGRF using MDRD(Modification of Diet in Renal Disease) method
Measured: until 24 weeks after taking medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start16 Mar 2021
- Primary completion10 Oct 2022 (estimated)
- Study completion22 Feb 2023 (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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Suk Suh, M.D., Ph.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867720
- Sponsor's protocol ID
- B95_03LT2001
- Acronym
- STELLA
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 30 Apr 2021
- 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 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Single Arm, Open-label, Phase 4 STudy to Evaluate the Efficacy and Safety of CertiroBELL® Tablet Plus TAcrolimus in Primary Living Donor Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT04867720
- Acronym / sponsor ID
- STELLA / B95_03LT2001
- Conditions
- Liver Transplant
- Keywords
- Everolimus, CertiroBell, Tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 22 Feb 2023 (estimated)
- First posted
- 30 Apr 2021 (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.
To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus
Detailed description
This study is multi-center, single arm, open-label, phase 4 study to evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus in primary living donor liver transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CertiroBell Tablet | Experimental | Drug: EverolimusUse in combination with Tacrolimus at least 6 months 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 (4 listed)
- Patients who had liver transplantation from living donor and had passed over 3 months since operation.
- Over 20 years old
- Patients who are being treated with Tacrolimus at screening visit
- Patients who agreed to written informed consent
Key exclusion criteria (22 listed)
- Patients who had received non-liver organs before liver transplantation or had received other organs while receiving liver.
- Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver
- Patients who have been diagnosed with acute rejection within 6 months and have been treated
- Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months
- Patients who have been diagnosed with malignant tumor within 5 years(however, the following will be excepted)
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 |
|---|---|---|
| EverolimusAlso: CertiroBell Tab.- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8mg/mL. | Drug | CertiroBell Tablet |
Primary outcome
Incidence of composite efficacy failure
Time frame: until 24 weeks after taking medicine
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
8 secondary outcomes
Incidence of biopsy-confirmed acute rejection
Time frame: until 24 weeks after taking medicine
Pathological result, time of occurrence, treatment method and treatment result of acute rejection confirmed by biopsy(over 4 points of RAI score)
Time frame: until 24 weeks after taking medicine
Survival rate of patients
Time frame: until 24 weeks after taking medicine
Survival rate of transplanted organ
Time frame: until 24 weeks after taking medicine
Incidence rate of liver cancer
Time frame: until 24 weeks after taking medicine
Recurrence rate of liver cancer
Time frame: until 24 weeks after taking medicine
Incidence rate of CMV infection
Time frame: until 24 weeks after taking medicine
Variation of serum creatinine, eGFR(estimated glomerular filtration rate) compared to baseline using MDRD(Modification of Diet in Renal Disease)
Time frame: until 24 weeks after taking medicine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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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.
Kyung-Suk Suh, M.D., Ph.D. study chair
Seoul National University Hospital
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 Everolimus 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 4 inclusion and 22 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 30 Apr 2021. 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?
Contact Kyung-Suk Suh, M.D., Ph.D. (82-2-2072-7200, kssuh@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite efficacy failure (time frame: until 24 weeks after taking medicine). 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 30 Apr 2021.