To Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients

Launched by JONGMAN KIM · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a medication called Tenofovir alafenamide (TAF) for patients who have had a liver transplant due to hepatitis B virus (HBV). The goal is to see how switching to TAF can help protect kidney function in these patients, as some antiviral medications can cause kidney problems. The study is important because reactivation of HBV after a liver transplant can lead to serious health issues, and current treatments may not be safe for everyone, especially those with existing kidney concerns.

To participate in this trial, patients need to be at least 19 years old and must have had stable liver function for a year after their transplant. They should also be currently taking antiviral medications for HBV but not TAF. Participants will undergo regular assessments to monitor their kidney health, the effectiveness of the treatment against HBV, and other health factors like cholesterol levels and bone health. The trial is not yet recruiting participants, but it offers a chance for eligible patients to contribute to important research that could help improve treatment for liver transplant patients in the future.

Gender

ALL

Eligibility 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:
• • 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.