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

NCT06589518 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-07-122
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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 reactivation post-liver transplantation can result in a post-transplant mortality rate of up to 50% within two years, making prophylaxis critical. Currently, a combination therapy of HBIG and nucleotide analogues is commonly used. Among the nucleotide analogues (NA), entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are frequently used as first-line therapies. However, both ETV and TDF have nephrotoxicity, requiring caution in patients with chronic kidney disease. Specifically, 18% of liver transplant patients develop chronic kidney disease due to immunosuppressant use, making the appropriate use of antiviral drugs to preserve renal function crucial. 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 exclusively on general chronic liver disease patients. Although multicenter studies have been reported for liver transplant patients, they were retrospective and involved a limited number of patients. Therefore, the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis. The secondary objectives are to evaluate the antiviral effect on HBV, the impact on lipid profiles, and the effectiveness in preserving bone density.

Conditions

Hepatitis B Virus; Liver Transplant; Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• The amount of eGFR change

  The amount of eGFR change at 12months after conversion compared to before TAF conversion

  Through study completion, an average of 12months

Secondary Outcomes (4)

• The amount of Creatinine change

  an average of 12months

• The amount of CKD stage change

  an average of 12months

• effectiveness

  Through study completion, an average of 12months

• BMD change

  an average of 12months

Study Arms (1)

Experimental(Tenofovir alafenamide)

EXPERIMENTAL

Tenofovir alafenamide is administered once every day with 25mg PO.

Drug: Tenofovir Alafenamide Citrate

Interventions

Tenofovir Alafenamide Citrate DRUG

Tenofovir alafenamide is administered once every day with 25mg PO for 48 weeks.

Also known as: Vemlia

Experimental(Tenofovir alafenamide)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with a history of hypersensitivity to Tenofovir. 9 . Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• \. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.

Sponsors & Collaborators

• Jongman Kim: lead

MeSH Terms

Conditions

Hepatitis B; Renal Insufficiency

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jongman Kim, Ph, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jongman Kim, Ph, MD

CONTACT

+82-10-9365-0277; jongman94.kim@samsung.com

Jongman Kim, Ph, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: September 19, 2024
• Study Start: March 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-02