Liver TransplantPhase 4MONTBLANCNCT04471441
Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.
A Phase 4 study testing Everolimus Tab. and Mycophenolate mofetil Tab./Cap. 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 CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients. 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 Tab. and Mycophenolate mofetil Tab./Cap.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2020to 24 Jul 2024
- 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
- [Time of screening]
- Patients who have transplanted in primary living donor liver in 35 days or who plan to be transplanted in primary living donor liver.
- Over 20 years old(male or female)
- Agreement with written informed consent
- [Time of randomization] - Patients who have transplanted liver within 4 weeks(25 days to 35 days)
Who cannot join
- [Time of screening]
- Patients who have transplanted non-liver organs or have plan to be transplanted non-liver organs.
- Patients with bioartificial liver (cell system)
- Patients who diagnosed with malignant tumor within 5 years [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 with severe systemic infection
- Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
Show all 18Show fewer
- Participated in other trial within 4 weeks
- In investigator's judgement
- [Time of randomization]
- Patients with acute rejection who have been clinically treated after liver transplantation.
- Patients with complication related to the hepatic artery such as hepatic artery thrombosis at the time of randomization.
- At screening
- WBC <1,500/mm^3 or PLT <30,000/mm^3 or over 3 times upper than normal range of liver function tests(T-bilirubin, AST, ALT) levels
- Protein/Creatinine ratio(urine test) > 1 or eGFR by MDRD< 30mL/min/1.73m^2 or Total cholesterol > 350mg/dL or triglycerides > 500mg/dL
- Patients taking HCV(hepatitis C virus) Therapeutic Drugs
- Patients who had plasmapheresis within 1 week.
- Patents who had a record of taking mTOR inhibitor before.
- In investigator's judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of CertiroBell® Compared With Mycophenolate Mofetil in Primary Living Donor Liver Transplant Recipients.
The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.
Read the detailed description
This study is multi-center, open-label, randomized controlled phase 4 study to evaluate the efficacy and safety of certirobell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.
On the first visit the patients scheduled to be operated liver transplant in 35 days will be conducted screening. Patients who meet the criteria of this clinical trial will be randomized to CertiroBell or mycophenolate mofetil on the second visit. Each group will take CertiroBell or mycophenolate mofetil and will conduct scheduled tests with 5 additional visits.
- Conditions
- Liver Transplant
- Being tested
- Everolimus Tab., Mycophenolate mofetil Tab./Cap.
- Keywords
- Everolimus, CertiroBell, Mycophenolate mofetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus Tab.Drug
Also called CertiroBell Tab.
After first dose 1mg BID(total 2mg daily PO), check the blood concentration of everolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~8ng/mL.
Mycophenolate mofetil Tab./Cap.Drug
Up to 1.5g BID(total 3g daily), PO
| Study group | Role | What they receive |
|---|---|---|
| CertiroBell Tablet | Experimental | De novo liver transplant recipients will be randomized after liver transplant operation. Receives: Drug: Everolimus Tab. |
| Mycophenolate mofetil Tablet/Capsule | Active comparator | De novo liver transplant recipients will be randomized after liver transplant operation. Receives: Drug: Mycophenolate mofetil Tab./Cap. |
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 (9)
Incidence of biopsy-confirmed acute rejection
acute rejection confirmed by result of biopsy(over 4 points of RAI score)
Measured: until 24weeks and 48weeks after taking medicine
The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy(over 4 points of RAI score)
details of acute rejection confirmed by result of biopsy(over 4 points of RAI score)
Measured: until 24weeks and 48weeks after taking medicine
Incidence of composite efficacy failure
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
Measured: until 48weeks after taking medicine
Survival rate of patients
Survival rate of patients
Measured: until 24weeks and 48weeks after taking medicine
Survival rate of transplanted organ
Survival rate of transplanted organ
Measured: until 24weeks and 48weeks after taking medicine
Incidence and recurrence rates of liver cancer
Incidence and recurrence rates of liver cancer
Measured: until 24weeks and 48weeks after taking medicine
Incidence and recurrence rates of HCV infection
Incidence and recurrence rates of HCV infection
Measured: until 24weeks and 48weeks after taking medicine
Incidence of CMV infection
Incidence of CMV infection
Measured: until 24weeks and 48weeks after taking medicine
variation of Serum creatinine, eGFR(estimated glomerular filtration rate) compared to the baseline
eGFR using MDRD(Modification of Diet in Renal Disease) method
Measured: at 24 weeks and 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start30 Jun 2020
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Jin Joo, M.D., Ph.D., Study chair, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471441
- Sponsor's protocol ID
- B95-02LT1903
- Acronym
- MONTBLANC
- Status last verified
- Feb 2025
- First submitted
- 10 Jul 2020
- Last updated
- 15 Apr 2026
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of CertiroBell® Compared With Mycophenolate Mofetil in Primary Living Donor Liver Transplant Recipients.
- ClinicalTrials.gov ID
- NCT04471441
- Acronym / sponsor ID
- MONTBLANC / B95-02LT1903
- Conditions
- Liver Transplant
- Keywords
- Everolimus, CertiroBell, Mycophenolate mofetil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 15 Jul 2020 (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 CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.
Detailed description
This study is multi-center, open-label, randomized controlled phase 4 study to evaluate the efficacy and safety of certirobell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.
On the first visit the patients scheduled to be operated liver transplant in 35 days will be conducted screening. Patients who meet the criteria of this clinical trial will be randomized to CertiroBell or mycophenolate mofetil on the second visit. Each group will take CertiroBell or mycophenolate mofetil and will conduct scheduled tests with 5 additional visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CertiroBell Tablet | Experimental | Drug: Everolimus Tab.De novo liver transplant recipients will be randomized after liver transplant operation. |
| Mycophenolate mofetil Tablet/Capsule | Active comparator | Drug: Mycophenolate mofetil Tab./Cap.De novo liver transplant recipients will be randomized after liver transplant operation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- [Time of screening]
- Patients who have transplanted in primary living donor liver in 35 days or who plan to be transplanted in primary living donor liver.
- Over 20 years old(male or female)
- Agreement with written informed consent
- [Time of randomization] - Patients who have transplanted liver within 4 weeks(25 days to 35 days)
Key exclusion criteria (18 listed)
- [Time of screening]
- Patients who have transplanted non-liver organs or have plan to be transplanted non-liver organs.
- Patients with bioartificial liver (cell system)
- Patients who diagnosed with malignant tumor within 5 years [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 with severe systemic infection
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 |
|---|---|---|
| Everolimus Tab.Also: CertiroBell Tab.After first dose 1mg BID(total 2mg daily PO), check the blood concentration of everolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~8ng/mL. | Drug | CertiroBell Tablet |
| Mycophenolate mofetil Tab./Cap.Up to 1.5g BID(total 3g daily), PO | Drug | Mycophenolate mofetil Tablet/Capsule |
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
9 secondary outcomes
Incidence of biopsy-confirmed acute rejection
Time frame: until 24weeks and 48weeks after taking medicine
The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy(over 4 points of RAI score)
Time frame: until 24weeks and 48weeks after taking medicine
Incidence of composite efficacy failure
Time frame: until 48weeks after taking medicine
Survival rate of patients
Time frame: until 24weeks and 48weeks after taking medicine
Survival rate of transplanted organ
Time frame: until 24weeks and 48weeks after taking medicine
Incidence and recurrence rates of liver cancer
Time frame: until 24weeks and 48weeks after taking medicine
Incidence and recurrence rates of HCV infection
Time frame: until 24weeks and 48weeks after taking medicine
Incidence of CMV infection
Time frame: until 24weeks and 48weeks after taking medicine
variation of Serum creatinine, eGFR(estimated glomerular filtration rate) compared to the baseline
Time frame: at 24 weeks and 48weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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.
Dong Jin Joo, M.D., Ph.D. study chair
Severance 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 Tab. and Mycophenolate mofetil Tab./Cap. 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 18 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: finished, as of the sponsor's last update on 15 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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 15 Apr 2026.