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NCT06589518
To Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients
Phase 2 trial testing Tenofovir Alafenamide Citrate in Hepatitis B Virus in 108 participants. Not yet recruiting.
31 March 2026
Quick facts
| Lead sponsor | Jongman Kim |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 108 |
| Start date | 1 March 2025 |
| Primary completion | 31 March 2026 |
| Estimated completion | 30 June 2026 |
Drugs / interventions tested
- Tenofovir Alafenamide Citrate — full drug profile →
Conditions studied
- Hepatitis B Virus — all drugs for Hepatitis B Virus →
- Liver Transplant — all drugs for Liver Transplant →
- Renal Insufficiency — all drugs for Renal Insufficiency →
Sponsor
Jongman Kim — full company profile →
Who can join
19 and older, any sex, with Hepatitis B Virus or Liver Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06589518
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Hepatitis B Virus
Currently open trials in the same condition.
- NCT06881238 — Impact of Hepatitis B Virus on Inflammatory Bowel Disease · recruiting
- NCT04231565 — Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA. · NA · recruiting
Other Jongman Kim trials
Trials by the same sponsor.
- NCT07267208 — A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06589518 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jongman Kim
- Last refreshed: 4 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06589518.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing