Safety IssuesPhase 4NCT05410496
Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection
A Phase 4 study testing Tenofovir Alafenamide 25 MG in people with Safety Issues and Chronic Hepatitis B, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
Trial summary
tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with chronic hepatitis B (CHB), therefore TAF may be a good option in kidney or liver transplant patients with chronic HBV infection. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Safety Issues, Chronic Hepatitis B, Transplant Recipient
- What is being tested?
- Tenofovir Alafenamide 25 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesTaiwan
- Study dates
- 22 Jun 2021to 30 Jul 2027
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 20 years of age
- Chronic HBV infection under NA therapy other than TAF
- Underwent kidney and/ or liver transplantation
- Without clinical or pathologic evidence of moderate or severe rejection
- Patients who are indicated for TAF switching therapy, such as concerns in virological response, biochemical response, drug compliance, or safety issues to other NAs.
Who cannot join
- End stage renal disease (eGFR < 15 mL/min/1.73m2)
- Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
- Any active malignancies
- Pregnant or breast-feeding women
- Known allergy to tenofovir-contained regimens
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
China Medical University Hospital
Taichung, 40447
About this study
Official title: A Prospective Cohort Study of Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic Hepatitis B Virus Infection
tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with chronic hepatitis B (CHB), therefore TAF may be a good option in kidney or liver transplant patients with chronic HBV infection. The aim of this prospective cohort study is to assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection.
Read the detailed description
Life-long nucleos(t)ide analogue (NA) therapy has been recommended in patients with chronic HBV infection after organ transplantation, therefore the safety of long-term NA therapy is particularly important in transplant patients. Entecavir, tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) are recommended drugs for CHB patients in current guidelines because of their high potency in antiviral efficacy and low rate in virological resistance. However, the data of TAF therapy in transplant patients remain limited.
The potential nephrotoxicity and a decrease in bone mineral density (BMD) of TDF therapy have been reported in previous studies. TAF is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at a much lower dose, thereby reducing systemic exposure to tenofovir. In the randomized controlled trials of TDF versus TAF showed that virological and serological results were similar in both arms. However, patients in TAF arm had improved renal effects and BMD as compared to TDF. Improvement in renal function and BMD were also found in chronic hepatitis B patients who switched from TDF to TAF. Furthermore, in some retrospective studies, switching from entecavir to TAF may present a superior efficacy in HBV DNA suppression and HBsAg level reduction, and renal safety was comparable between the TAF switch group and the entecavir continuation group. Interestingly, switching from entecavir to TAF is associated with improvement of the medication adherence, which may be particularly important to patients under long-term NA therapy.
The clinical data of TAF therapy in transplant patients remain very limited, particularly in kidney transplant patients. With a high virological response rate and a low adverse effect (AE) rate in patients with CHB, TAF may be a good option for patients underwent liver or kidney transplantation.The aim of this study is to assess the safety, drug adherence, and efficacy of TAF switching therapy in kidney or liver or transplant patients with chronic HBV infection.
- Conditions
- Safety Issues, Chronic Hepatitis B, Transplant Recipient
- Being tested
- Tenofovir Alafenamide 25 MG
- Keywords
- renal function, hepatitis, patient adherence
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Alafenamide 25 MGDrug
Also called TAF
To assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection.
| Study group | Role | What they receive |
|---|---|---|
| TAF switching therapy cohort | Experimental | A prospective single-arm cohort to evaluate the safety, drug adherence, and efficacy of TAF switching therapy in kidney or liver or transplant patients with chronic HBV infection. Receives: Drug: Tenofovir Alafenamide 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated glomerular filtration rate
0-120 ml/min/1.73m2 (higher scores mean a better outcome)
Measured: week 48
HBV viral load
0-8 log10 IU/mL; blood HBV DNA level (higher scores mean a worse outcome)
Measured: week 48
Drug adherence score
Score 1-8; Morisky Medication Adherence Scale-8 questionnaire
Measured: week 48 (higher scores mean a better outcome)
Secondary outcomes (7)
Estimated glomerular filtration rate
0-120 ml/min/1.73m2 (higher scores mean a better outcome)
Measured: week 144
HBV viral load
0-8 log10 IU/mL; blood HBV DNA level (higher scores mean a worse outcome)
Measured: week 144
Drug adherence score
Score 1-8; Morisky Medication Adherence Scale-8 questionnaire
Measured: week 144 (higher scores mean a better outcome)
Bone mineral density
0-5 g/cm2; dual-energy X-ray absorptiometry (higher scores mean a better outcome)
Measured: week 144
Alanine aminotransferase
0-150000 IU/mL; blood ALT level (higher scores mean a worse outcome)
Measured: week 144
Quantitative HBsAg
0-10000 IU/mL; blood qHBsAg level (higher scores mean a worse outcome)
Measured: week 144
Liver fibrosis elastography
0-30 kPa; ultrasound elastography (higher scores mean a worse outcome)
Measured: week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start22 Jun 2021
- Primary completion30 May 2024
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Adherence to Medication
- Responsible party
- Sponsor
- Investigators
- Teng-Yu Lee, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410496
- Sponsor's protocol ID
- CF21160B
- Status last verified
- Apr 2026
- First submitted
- 13 May 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.
PubMed 29405329European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
PubMed 28427875Tsai HJ, Chuang YW, Lee SW, Wu CY, Yeh HZ, Lee TY. Using the chronic kidney disease guidelines to evaluate the renal safety of tenofovir disoproxil fumarate in hepatitis B patients. Aliment Pharmacol Ther. 2018 Jun;47(12):1673-1681. doi: 10.1111/apt.14682. Epub 2018 Apr 25.
PubMed 29696665Casado JL. Renal and Bone Toxicity with the Use of Tenofovir: Understanding at the End. AIDS Rev. 2016 Apr-Jun;18(2):59-68.
PubMed 27230467Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22.
PubMed 28404091Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, Hui AJ, Lim YS, Mehta R, Janssen HL, Acharya SK, Flaherty JF, Massetto B, Cathcart AL, Kim K, Gaggar A, Subramanian GM, McHutchison JG, Pan CQ, Brunetto M, Izumi N, Marcellin P; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):196-206. doi: 10.1016/S2468-1253(16)30107-8. Epub 2016 Sep 22.
PubMed 28404092Lampertico P, Buti M, Fung S, Ahn SH, Chuang WL, Tak WY, Ramji A, Chen CY, Tam E, Bae H, Ma X, Flaherty JF, Gaggar A, Lau A, Liu Y, Wu G, Suri V, Tan SK, Subramanian GM, Trinh H, Yoon SK, Agarwal K, Lim YS, Chan HLY. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020 May;5(5):441-453. doi: 10.1016/S2468-1253(19)30421-2. Epub 2020 Feb 20.
PubMed 32087795Li ZB, Li L, Niu XX, Chen SH, Fu YM, Wang CY, Liu Y, Shao Q, Chen G, Ji D. Switching from entecavir to tenofovir alafenamide for chronic hepatitis B patients with low-level viraemia. Liver Int. 2021 Jun;41(6):1254-1264. doi: 10.1111/liv.14786. Epub 2021 Jan 19.
PubMed 33404182Hagiwara S, Nishida N, Ida H, Ueshima K, Minami Y, Takita M, Komeda Y, Kudo M. Switching from entecavir to tenofovir alafenamide versus maintaining entecavir for chronic hepatitis B. J Med Virol. 2019 Oct;91(10):1804-1810. doi: 10.1002/jmv.25515. Epub 2019 Jul 2.
PubMed 31199513Kumada T, Toyoda H, Tada T, Yasuda S, Miyake N, Tanaka J. Comparison of the impact of tenofovir alafenamide and entecavir on declines of hepatitis B surface antigen levels. Eur J Gastroenterol Hepatol. 2021 Feb 1;32(2):255-260. doi: 10.1097/MEG.0000000000001733.
PubMed 32282538Ogawa E, Nomura H, Nakamuta M, Furusyo N, Koyanagi T, Dohmen K, Ooho A, Satoh T, Kawano A, Kajiwara E, Takahashi K, Azuma K, Kato M, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Tenofovir alafenamide after switching from entecavir or nucleos(t)ide combination therapy for patients with chronic hepatitis B. Liver Int. 2020 Jul;40(7):1578-1589. doi: 10.1111/liv.14482. Epub 2020 Apr 30.
PubMed 32304611Uchida Y, Nakao M, Tsuji S, Uemura H, Kouyama JI, Naiki K, Motoya D, Sugawara K, Nakayama N, Imai Y, Tomiya T, Mochida S. Significance of switching of the nucleos(t)ide analog used to treat Japanese patients with chronic hepatitis B virus infection from entecavir to tenofovir alafenamide fumarate. J Med Virol. 2020 Mar;92(3):329-338. doi: 10.1002/jmv.25644. Epub 2019 Dec 9.
PubMed 31777965Rashidi-Alavijeh J, Straub K, Achterfeld A, Wedemeyer H, Willuweit K, Herzer K. Safety and efficacy of tenofovir alafenamide in liver transplant recipients: A single center experience. Transpl Infect Dis. 2021 Jun;23(3):e13522. doi: 10.1111/tid.13522. Epub 2020 Dec 22.
PubMed 33217163Sripongpun P, Mannalithara A, Kwo PY, Kim WR. Potential Benefits of Switching Liver Transplant Recipients to Tenofovir Alafenamide Prophylaxis. Clin Gastroenterol Hepatol. 2020 Mar;18(3):747-749. doi: 10.1016/j.cgh.2019.05.057. Epub 2019 Jun 11.
PubMed 31271737
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT05410496
- Acronym / sponsor ID
- CF21160B
- Conditions
- Safety Issues, Chronic Hepatitis B, Transplant Recipient
- Keywords
- renal function, hepatitis, patient adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Institute of Adherence to Medication
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 8 Jun 2022 (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.
tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with chronic hepatitis B (CHB), therefore TAF may be a good option in kidney or liver transplant patients with chronic HBV infection. The aim of this prospective cohort study is to assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection.
Detailed description
Life-long nucleos(t)ide analogue (NA) therapy has been recommended in patients with chronic HBV infection after organ transplantation, therefore the safety of long-term NA therapy is particularly important in transplant patients. Entecavir, tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) are recommended drugs for CHB patients in current guidelines because of their high potency in antiviral efficacy and low rate in virological resistance. However, the data of TAF therapy in transplant patients remain limited.
The potential nephrotoxicity and a decrease in bone mineral density (BMD) of TDF therapy have been reported in previous studies. TAF is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at a much lower dose, thereby reducing systemic exposure to tenofovir. In the randomized controlled trials of TDF versus TAF showed that virological and serological results were similar in both arms. However, patients in TAF arm had improved renal effects and BMD as compared to TDF. Improvement in renal function and BMD were also found in chronic hepatitis B patients who switched from TDF to TAF. Furthermore, in some retrospective studies, switching from entecavir to TAF may present a superior efficacy in HBV DNA suppression and HBsAg level reduction, and renal safety was comparable between the TAF switch group and the entecavir continuation group. Interestingly, switching from entecavir to TAF is associated with improvement of the medication adherence, which may be particularly important to patients under long-term NA therapy.
The clinical data of TAF therapy in transplant patients remain very limited, particularly in kidney transplant patients. With a high virological response rate and a low adverse effect (AE) rate in patients with CHB, TAF may be a good option for patients underwent liver or kidney transplantation.The aim of this study is to assess the safety, drug adherence, and efficacy of TAF switching therapy in kidney or liver or transplant patients with chronic HBV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAF switching therapy cohort | Experimental | Drug: Tenofovir Alafenamide 25 MGA prospective single-arm cohort to evaluate the safety, drug adherence, and efficacy of TAF switching therapy in kidney or liver or transplant patients with chronic HBV infection. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 20 years of age
- Chronic HBV infection under NA therapy other than TAF
- Underwent kidney and/ or liver transplantation
- Without clinical or pathologic evidence of moderate or severe rejection
- Patients who are indicated for TAF switching therapy, such as concerns in virological response, biochemical response, drug compliance, or safety issues to other NAs.
Key exclusion criteria (5 listed)
- End stage renal disease (eGFR < 15 mL/min/1.73m2)
- Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
- Any active malignancies
- Pregnant or breast-feeding women
- Known allergy to tenofovir-contained regimens
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 25 MGAlso: TAFTo assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection. | Drug | TAF switching therapy cohort |
Primary outcome
Estimated glomerular filtration rate
Time frame: week 48
0-120 ml/min/1.73m2 (higher scores mean a better outcome)
HBV viral load
Time frame: week 48
0-8 log10 IU/mL; blood HBV DNA level (higher scores mean a worse outcome)
Drug adherence score
Time frame: week 48 (higher scores mean a better outcome)
Score 1-8; Morisky Medication Adherence Scale-8 questionnaire
7 secondary outcomes
Estimated glomerular filtration rate
Time frame: week 144
HBV viral load
Time frame: week 144
Drug adherence score
Time frame: week 144 (higher scores mean a better outcome)
Bone mineral density
Time frame: week 144
Alanine aminotransferase
Time frame: week 144
Quantitative HBsAg
Time frame: week 144
Liver fibrosis elastography
Time frame: week 144
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 May 2026.
- Results publication: PubMed 29405329Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.
- Results publication: PubMed 28427875European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
- Results publication: PubMed 29696665Tsai HJ, Chuang YW, Lee SW, Wu CY, Yeh HZ, Lee TY. Using the chronic kidney disease guidelines to evaluate the renal safety of tenofovir disoproxil fumarate in hepatitis B patients. Aliment Pharmacol Ther. 2018 Jun;47(12):1673-1681. doi: 10.1111/apt.14682. Epub 2018 Apr 25.
- Results publication: PubMed 27230467Casado JL. Renal and Bone Toxicity with the Use of Tenofovir: Understanding at the End. AIDS Rev. 2016 Apr-Jun;18(2):59-68.
- Results publication: PubMed 28404091Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22.
- Results publication: PubMed 28404092Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, Hui AJ, Lim YS, Mehta R, Janssen HL, Acharya SK, Flaherty JF, Massetto B, Cathcart AL, Kim K, Gaggar A, Subramanian GM, McHutchison JG, Pan CQ, Brunetto M, Izumi N, Marcellin P; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):196-206. doi: 10.1016/S2468-1253(16)30107-8. Epub 2016 Sep 22.
- Results publication: PubMed 32087795Lampertico P, Buti M, Fung S, Ahn SH, Chuang WL, Tak WY, Ramji A, Chen CY, Tam E, Bae H, Ma X, Flaherty JF, Gaggar A, Lau A, Liu Y, Wu G, Suri V, Tan SK, Subramanian GM, Trinh H, Yoon SK, Agarwal K, Lim YS, Chan HLY. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020 May;5(5):441-453. doi: 10.1016/S2468-1253(19)30421-2. Epub 2020 Feb 20.
- Results publication: PubMed 33404182Li ZB, Li L, Niu XX, Chen SH, Fu YM, Wang CY, Liu Y, Shao Q, Chen G, Ji D. Switching from entecavir to tenofovir alafenamide for chronic hepatitis B patients with low-level viraemia. Liver Int. 2021 Jun;41(6):1254-1264. doi: 10.1111/liv.14786. Epub 2021 Jan 19.
- Results publication: PubMed 31199513Hagiwara S, Nishida N, Ida H, Ueshima K, Minami Y, Takita M, Komeda Y, Kudo M. Switching from entecavir to tenofovir alafenamide versus maintaining entecavir for chronic hepatitis B. J Med Virol. 2019 Oct;91(10):1804-1810. doi: 10.1002/jmv.25515. Epub 2019 Jul 2.
- Results publication: PubMed 32282538Kumada T, Toyoda H, Tada T, Yasuda S, Miyake N, Tanaka J. Comparison of the impact of tenofovir alafenamide and entecavir on declines of hepatitis B surface antigen levels. Eur J Gastroenterol Hepatol. 2021 Feb 1;32(2):255-260. doi: 10.1097/MEG.0000000000001733.
- Results publication: PubMed 32304611Ogawa E, Nomura H, Nakamuta M, Furusyo N, Koyanagi T, Dohmen K, Ooho A, Satoh T, Kawano A, Kajiwara E, Takahashi K, Azuma K, Kato M, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Tenofovir alafenamide after switching from entecavir or nucleos(t)ide combination therapy for patients with chronic hepatitis B. Liver Int. 2020 Jul;40(7):1578-1589. doi: 10.1111/liv.14482. Epub 2020 Apr 30.
- Results publication: PubMed 31777965Uchida Y, Nakao M, Tsuji S, Uemura H, Kouyama JI, Naiki K, Motoya D, Sugawara K, Nakayama N, Imai Y, Tomiya T, Mochida S. Significance of switching of the nucleos(t)ide analog used to treat Japanese patients with chronic hepatitis B virus infection from entecavir to tenofovir alafenamide fumarate. J Med Virol. 2020 Mar;92(3):329-338. doi: 10.1002/jmv.25644. Epub 2019 Dec 9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Teng-Yu Lee, MD, PhD principal investigator
Taichung Veterans General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir Alafenamide 25 MG in people with Safety Issues and Chronic Hepatitis B, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated glomerular filtration rate (time frame: week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410496, which also lists 14 linked publications.
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 May 2026.