Hepatitis B VirusPhase 2NCT06589518
To Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients
A Phase 2 study testing Tenofovir Alafenamide Citrate in people with Hepatitis B Virus and Liver Transplant, run by Jongman Kim.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis B Virus, Liver Transplant, Renal Insufficiency
- What is being tested?
- Tenofovir Alafenamide Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jongman Kim, Ph, MD contact
About this study
Official title: A Prospective, Single Center Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients
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.
Read more
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.
Read the 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 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
- Being tested
- Tenofovir Alafenamide Citrate
- Medical subject headings
- Hepatitis B, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Alafenamide CitrateDrug
Also called Vemlia
Tenofovir alafenamide is administered once every day with 25mg PO for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental(Tenofovir alafenamide) | Experimental | Tenofovir alafenamide is administered once every day with 25mg PO. Receives: Drug: Tenofovir Alafenamide Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of eGFR change
The amount of eGFR change at 12months after conversion compared to before TAF conversion
Measured: Through study completion, an average of 12months
Secondary outcomes (4)
The amount of Creatinine change
Creatinine status by 12 months after conversion compared to before TAF conversion
Measured: an average of 12months
The amount of CKD stage change
CKD stage status by 12 months after conversion compared to before TAF conversion
Measured: an average of 12months
effectiveness
HBV recurrence rate
Measured: Through study completion, an average of 12months
BMD change
BMD status by 12 months after conversion compared to before TAF conversion
Measured: an average of 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jongman Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jongman Kim, Samsung Medical Center
- Investigators
- Jongman Kim, Ph, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589518
- Sponsor's protocol ID
- 2024-07-122
- Status last verified
- Feb 2025
- First submitted
- 31 Jul 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT06589518
- Acronym / sponsor ID
- 2024-07-122
- Conditions
- Hepatitis B Virus, Liver Transplant, Renal Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Jongman KimUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental(Tenofovir alafenamide) | Experimental | Drug: Tenofovir Alafenamide CitrateTenofovir alafenamide is administered once every day with 25mg PO. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Alafenamide CitrateAlso: VemliaTenofovir alafenamide is administered once every day with 25mg PO for 48 weeks. | Drug | Experimental(Tenofovir alafenamide) |
Primary outcome
The amount of eGFR change
Time frame: Through study completion, an average of 12months
The amount of eGFR change at 12months after conversion compared to before TAF conversion
4 secondary outcomes
The amount of Creatinine change
Time frame: an average of 12months
The amount of CKD stage change
Time frame: an average of 12months
effectiveness
Time frame: Through study completion, an average of 12months
BMD change
Time frame: an average of 12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jongman Kim, Ph, MD contact
Jongman Kim, Ph, MD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenofovir Alafenamide Citrate in people with Hepatitis B Virus and Liver Transplant, run by Jongman Kim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jongman Kim, Ph, MD (+82-10-9365-0277, jongman94.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of eGFR change (time frame: Through study completion, an average of 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.