A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 主要终点
- Change in eGFR at week 48
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Entecavell ODT
Entecavir ODT is administered once every day with 0.5mg PO
干预措施: Entecavell ODT (Drug)
结局指标
主要结局
Change in eGFR at week 48
时间窗: Baseline to week 48
Change in eGFR from baseline to week 48 following ETV-ODT conversion
次要结局
- 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)
- Incidence of graft failure and mortality(Baseline to week 48)
- Change in medication adherence(Baseline to week 48)
研究者
Jongman Kim
Professor
Samsung Medical Center