NCT07267208

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Jongman Kim · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Entecavell ODT	Entecavir ODT is administered once every day with 0.5mg PO for 48 weeks.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-12-05
• Last updated: 2025-12-05