NCT07267208Not yet recruitingPhase 2
A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 1 Dec 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Jongman Kim
- Diseases
- Hepatitis B
- NCT number
- NCT07267208
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 82
- From 1 Dec 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Patients with a history of hypersensitivity to Entecavir.
Lab values
- Patients with eGFR \<30 or those undergoing dialysis
Other
- 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 who are deemed unsuitable for participation in the clinical trial by the investigator.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.