Status:
NOT_YET_RECRUITING
To Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients
Lead Sponsor:
Jongman Kim
Conditions:
Hepatitis B Virus
Liver Transplant
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This clinical trial aims to confirm the efficacy and safety of Vemlia® tablets (Tenofovir alafenamide) in liver transplant patients with hepatitis B, focusing on their effects on renal function. HBV ...
Detailed Description
TAF has been reported through RCTs to be more effective than TDF in preserving renal function and bone density, while showing similar antiviral effects. However, these studies have been conducted excl...
Eligibility Criteria
Inclusion
- 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:
- ALT \< 3 x ULN and AST \< 3 x ULN
- Patients taking antiviral therapy other than TAF for HBV prophylaxis.
- Patients with a tacrolimus trough level maintained between 3-10 ng/mL.
- 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
- Patients who have undergone transplantation of organs other than the liver or re-transplantation.
- Patients who have received BAL system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.
- Patients with concurrent viral infections (HCV, HIV).
- Patients taking mTOR inhibitors (e.g., Everolimus (Certican), etc.).
- 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.
- 8 . Patients with a history of hypersensitivity to Tenofovir. 9 . Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- 10\. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06589518
Start Date
March 1 2025
End Date
June 30 2026
Last Update
February 4 2025
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