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to evaluate the efficacy and safety of Tenofovir alafenamide conversion in liver transplant patients

A prospective, Single center study to evaluate the efficacy and safety of Tenofovir alafenamide conversion in liver transplant patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0009960
Enrollment
108
Registered
2024-11-28
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A patient who has undergone liver transplantation due to hepatitis B and agrees to participate in the clinical trial one year after the surgery by signing the informed consent form will have th

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 19 years or older. 2. 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 3. Patients taking antiviral therapy other than TAF for HBV prophylaxis. 4. 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.

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone transplantation of organs other than the liver or re-transplantation. 2. Patients who have received BAL system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation. 3. Patients with concurrent viral infections (HCV, HIV). 4. Patients taking mTOR inhibitors (e.g., Everolimus (Certican), etc.). 5. Patients with eGFR <30 or those undergoing dialysis. 6. Pregnant or breastfeeding women. 7. 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.

Design outcomes

Primary

MeasureTime frame
The amount of eGFR change after conversion compared to before TAF conversion

Secondary

MeasureTime frame
Creatinine, CKD stage, Cholesterol status, Spinal and Hip BMD status and proteinuria variation after conversion compared to before TAF conversion;HBV recurrence rate

Countries

Korea, Republic of

Contacts

Public ContactJongman Kim

Samsung Medical Center

jongman94@hanmail.net+82-2-3410-1719

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026