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Liver transplant patients get new hope: CertiroBell vs standard drug

NCT ID NCT04471441

Disease control Sponsor: Chong Kun Dang Pharmaceutical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether CertiroBell (everolimus) works better than mycophenolate mofetil at preventing organ rejection, graft loss, or death in 150 adults who received a liver transplant from a living donor. Participants took one of the two drugs for up to a year. The goal was to see which drug keeps the new liver healthier with fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Everolimus (CertiroBell tablet)
What this could lead to
If successful, this could offer a safer or more effective way to prevent organ rejection after liver transplant, reducing the need for lifelong anti-rejection drugs.
What could go wrong
This is a completed Phase 4 trial with 150 participants, so results are available but may not apply to all transplant patients. Everolimus can cause side effects like infections or mouth sores.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

150 people

The number who actually took part.

Started

Jun 2020

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

\* Inclusion Criteria: \[Time of screening\] * 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) \* Exclusion Criteria \[Time of screening\] * 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 * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver transplant

Contacts and locations

Locations

  • Severance Hospital

    Seoul, South Korea

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