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

NCT07267208 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-09-055
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Hepatitis B Virus; Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Change in eGFR at week 48

  Change in eGFR from baseline to week 48 following ETV-ODT conversion

  Baseline to week 48

Secondary Outcomes (6)

• Change in Creatinine, cystatin C profile

  Baseline to week 48

• Change in CKD stage

  Baseline to week 48

• Incidence of HBV recurrence

  Baseline to week 48

• Change in cholesterol status, proteinuria and liver stiffness

  Baseline to week 48

• Change in medication adherence

  Baseline to week 48

Study Arms (1)

Entecavell ODT

EXPERIMENTAL

Entecavir ODT is administered once every day with 0.5mg PO

Drug: Entecavell ODT

Interventions

Entecavell ODT DRUG

Entecavir ODT is administered once every day with 0.5mg PO for 48 weeks.

Entecavell ODT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \* 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.

Sponsors & Collaborators

• Jongman Kim: lead

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Jongman Kim, Ph, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jongman Kim, Ph, MD

CONTACT

+82-10-9365-0277; jongman94.kim@samsung.com

Jongman Kim, Ph, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11