Hepatitis B VirusPhase 2NCT07267208
A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients
A Phase 2 study testing Entecavell ODT in people with Hepatitis B Virus and Liver Transplant, run by Jongman Kim.
Trial summary
This clinical study aims to evaluate the efficacy and safety of switching to entecavir orally disintegrating tablets (ETV-ODT) in liver transplant recipients with chronic hepatitis B, with a particular focus on the impact of the conversion on renal function. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis B Virus, Liver Transplant
- What is being tested?
- Entecavell ODT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 years or older.
- Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:
- AST and ALT < 35IU/L
- HBsAg: Negative
- HBV DNA: Not detected
- Patients who have been taking entecavir for HBV prophylaxis for at least 1 year.
- Patients with a tacrolimus trough level maintained between 3-10 ng/mL. 5 .Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.
Who cannot join
- Patients who have undergone transplantation of organs other than the liver or re-transplantation.
- Patients who have received bioartificial liver system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.
- Patients with concurrent viral infections (HCV, HIV).
- Patients with eGFR <30 or those undergoing dialysis
- Pregnant or breastfeeding women.
- Patients or their spouses/partners who do not agree to use medically acceptable and appropriate contraception methods* during the clinical trial period.
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- Appropriate contraception methods: hormonal contraception, intrauterine device (IUC or IUS), tubal ligation, tubal occlusion, hysterectomy, vasectomy, double barrier methods (combined use of male or female condoms with cervical caps, diaphragms, or contraceptive sponges), single barrier methods with spermicide.
- Patients with a history of hypersensitivity to Entecavir.
- Patients who are deemed unsuitable for participation in the clinical trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jongman Kim, Ph, MD contact
About this study
This clinical study aims to evaluate the efficacy and safety of switching to entecavir orally disintegrating tablets (ETV-ODT) in liver transplant recipients with chronic hepatitis B, with a particular focus on the impact of the conversion on renal function.
After providing written informed consent, participants will undergo screening assessments to determine eligibility based on the inclusion and exclusion criteria. Eligible participants who receive the investigational product will visit the study site at predetermined time points over a 48-week period to complete the scheduled study procedures.
Read the detailed description
This study aims to evaluate the antiviral efficacy, safety, and potential improvement in medication adherence after converting stable liver transplant recipients to Entecabell ODT. Only participants who meet all inclusion and exclusion criteria will receive the investigational product. After conversion, participants will take Entecabell ODT 0.5 mg once daily for 48 weeks and will be followed according to the scheduled visits and assessments.
The primary objective of the study is to assess the impact of switching from entecavir tablets to Entecabell ODT on renal function in liver transplant recipients receiving entecavir for HBV prophylaxis. Secondary objectives include evaluating the antiviral effect against HBV and the potential improvement in medication adherence following conversion to Entecabell ODT.
- Conditions
- Hepatitis B Virus, Liver Transplant
- Being tested
- Entecavell ODT
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavell ODTDrug
Entecavir ODT is administered once every day with 0.5mg PO for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Entecavell ODT | Experimental | Entecavir ODT is administered once every day with 0.5mg PO Receives: Drug: Entecavell ODT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eGFR at week 48
Change in eGFR from baseline to week 48 following ETV-ODT conversion
Measured: Baseline to week 48
Secondary outcomes (6)
Change in Creatinine, cystatin C profile
Change in Creatinine, cystatin C profile from baseline to week 48 following ETV-ODT conversion
Measured: Baseline to week 48
Change in CKD stage
Change in the proportion of participants by CKD stage from baseline to Week 48 following ETV-ODT conversion
Measured: Baseline to week 48
Incidence of HBV recurrence
Incidence of HBV recurrence
Measured: Baseline to week 48
Change in cholesterol status, proteinuria and liver stiffness
Change in cholesterol status (LDL, HDL, total cholesterol, triglycerides), proteinuria (protein-to-creatinine ratio and albumin-to-creatinine ratio), and liver stiffness by FibroScan from baseline to Week 48 following ETV-ODT conversion
Measured: Baseline to week 48
Change in medication adherence
Change in medication adherence from baseline to Week 48 following ETV-ODT conversion
Measured: Baseline to week 48
Incidence of graft failure and mortality
Incidence of graft failure and mortality
Measured: Baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jongman Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jongman Kim, Samsung Medical Center
- Investigators
- Jongman Kim, Ph, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267208
- Sponsor's protocol ID
- 2025-09-055
- Status last verified
- Oct 2026
- First submitted
- 24 Nov 2025
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT07267208
- Acronym / sponsor ID
- 2025-09-055
- Conditions
- Hepatitis B Virus, Liver Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Jongman KimUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Dec 2025 (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.
This clinical study aims to evaluate the efficacy and safety of switching to entecavir orally disintegrating tablets (ETV-ODT) in liver transplant recipients with chronic hepatitis B, with a particular focus on the impact of the conversion on renal function.
After providing written informed consent, participants will undergo screening assessments to determine eligibility based on the inclusion and exclusion criteria. Eligible participants who receive the investigational product will visit the study site at predetermined time points over a 48-week period to complete the scheduled study procedures.
Detailed description
This study aims to evaluate the antiviral efficacy, safety, and potential improvement in medication adherence after converting stable liver transplant recipients to Entecabell ODT. Only participants who meet all inclusion and exclusion criteria will receive the investigational product. After conversion, participants will take Entecabell ODT 0.5 mg once daily for 48 weeks and will be followed according to the scheduled visits and assessments.
The primary objective of the study is to assess the impact of switching from entecavir tablets to Entecabell ODT on renal function in liver transplant recipients receiving entecavir for HBV prophylaxis. Secondary objectives include evaluating the antiviral effect against HBV and the potential improvement in medication adherence following conversion to Entecabell ODT.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entecavell ODT | Experimental | Drug: Entecavell ODTEntecavir ODT is administered once every day with 0.5mg PO |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 19 years or older.
- Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:
- Patients who have been taking entecavir for HBV prophylaxis for at least 1 year.
- Patients with a tacrolimus trough level maintained between 3-10 ng/mL. 5 .Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.
Key exclusion criteria (9 listed)
- Patients who have undergone transplantation of organs other than the liver or re-transplantation.
- Patients who have received bioartificial liver system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.
- Patients with concurrent viral infections (HCV, HIV).
- Patients with eGFR <30 or those undergoing dialysis
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Entecavell ODTEntecavir ODT is administered once every day with 0.5mg PO for 48 weeks. | Drug | Entecavell ODT |
Primary outcome
Change in eGFR at week 48
Time frame: Baseline to week 48
Change in eGFR from baseline to week 48 following ETV-ODT conversion
6 secondary outcomes
Change in Creatinine, cystatin C profile
Time frame: Baseline to week 48
Change in CKD stage
Time frame: Baseline to week 48
Incidence of HBV recurrence
Time frame: Baseline to week 48
Change in cholesterol status, proteinuria and liver stiffness
Time frame: Baseline to week 48
Change in medication adherence
Time frame: Baseline to week 48
Incidence of graft failure and mortality
Time frame: Baseline to week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 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.
Jongman Kim, Ph, MD contact
Jongman Kim, Ph, MD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Entecavell ODT in people with Hepatitis B Virus and Liver Transplant, run by Jongman Kim.
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 7 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jongman Kim, Ph, MD (+82-10-9365-0277, jongman94.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eGFR at week 48 (time frame: Baseline to week 48). 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 Oct 2026.