A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant; Hepatitis B Virus
• Intervention / Treatment: Drug: Entecavell ODT

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 Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jongman Kim, Ph, MD; Phone Number: +82-10-9365-0277; Email: jongman94.kim@samsung.com
• Study Contact Backup: Name: Jongman Kim, Ph, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged 19 years or older.

2. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:

   1. AST and ALT < 35IU/L
   2. HBsAg: Negative
   3. HBV DNA: Not detected
3. Patients who have been taking entecavir for HBV prophylaxis for at least 1 year.
4. 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.

Exclusion Criteria:

1. Patients who have undergone transplantation of organs other than the liver or re-transplantation.
2. Patients who have received bioartificial liver system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.
3. Patients with concurrent viral infections (HCV, HIV).
4. Patients with eGFR <30 or those undergoing dialysis
5. Pregnant or breastfeeding women.

6. Patients or their spouses/partners who do not agree to use medically acceptable and appropriate contraception methods* during the clinical trial period.

   * 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.

7. Patients with a history of hypersensitivity to Entecavir.
8. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Entecavell ODT; Entecavir ODT is administered once every day with 0.5mg PO	Drug: Entecavell ODT; Entecavir ODT is administered once every day with 0.5mg PO for 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eGFR at week 48	Change in eGFR from baseline to week 48 following ETV-ODT conversion	Baseline to week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Creatinine, cystatin C profile	Change in Creatinine, cystatin C profile from baseline to week 48 following ETV-ODT conversion	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	Baseline to week 48
Incidence of HBV recurrence	Incidence of HBV recurrence	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	Baseline to week 48
Change in medication adherence	Change in medication adherence from baseline to Week 48 following ETV-ODT conversion	Baseline to week 48
Incidence of graft failure and mortality	Incidence of graft failure and mortality	Baseline to week 48

Collaborators and Investigators

• Sponsor: Jongman Kim
• Investigators: Principal Investigator: Jongman Kim, Ph, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B
• Other Study ID Numbers: 2025-09-055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No