Chronic Hepatitis bPhase 4CHANGENCT04496882
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
A Phase 4 study testing Vemlidy in people with Chronic Hepatitis b and Hepatitis B Reactivation, run by National Taiwan University Hospital at 8 sites in Taiwan.
Trial summary
We will conduct a phase 4, multicenter, open-label trial at 8 academic centers in Taiwan. Chronic hepatitis B patients receiving oral antiviral therapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF]) for at least 1 year, and fulfil the following nucleos(t)ide analogs discontinuation criteria. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Chronic Hepatitis b, Hepatitis B Reactivation
- What is being tested?
- Vemlidy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 8 sitesTaiwan
- Study dates
- 9 Sep 2020to 31 Dec 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 1 years, and fulfil the following NUCs discontinuation criteria (1)HBeAg-positive patients achieved HBeAg loss, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieved virological remission (HBV DNA <20 IU/mL) for more than 1 year
- After NUC discontinuation, patients had a clinical relapse (HBV DNA > 2000 IU/mL, and ALT > 2x ULN)
- The retreatment regimen switches to TAF (within 3.3 months of clinical relapse)
- Historical continuing therapy cohort
- Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 1 years, and fulfil the following NUCs discontinuation criteria (1) HBeAg-positive patients achieved HBeAg loss, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieved virological remission (HBV DNA <20 IU/mL) for more than 1 year
- After NUC discontinuation, patients had a clinical relapse (HBV DNA > 2000 IU/mL, and ALT > 2x ULN)
- The patients continued the original regimen (ETV, TDF) for retreatment (within 3.3 months of clinical relapse)
Who cannot join
- Patients who do not fulfill the discontinuation criteria
- Patients who have HCV, HDV or HIV co-infection
- Patients who discontinue lamivudine, adefovir, or telbivudine therapy
- Patients with liver cirrhosis by ultrasonography and clinical diagnosis
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Buddhist Tzu Chi General Hospital, Da-Lin Branch
Chiayi City
Chia-Yi Christian Hospital
Chiayi City
National Taiwan University Hospital, Yun-Lin branch
Douliu
National Taiwan University Hospital ,Hsin-Chu Branch
Hsinchu
E-da hospital
Kaohsiung City
National Taiwan University Hospital
Taipei, 100
Buddhist Tzu-Chi General Hospital Taipei Branch
Taipei
Taipei City Hospital, Renai Branch
Taipei
About this study
Official title: The Clinical Efficacy of Tenofovir Alafenamide-switching Therapy in Patients With Chronic Hepatitis B Experiencing Clinical Flare-up After Discontinuation of Nucleos[t]Ide Analogues Therapy
We will conduct a phase 4, multicenter, open-label trial at 8 academic centers in Taiwan.
Chronic hepatitis B patients receiving oral antiviral therapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF]) for at least 1 year, and fulfil the following nucleos(t)ide analogs discontinuation criteria. After nucleos(t)ide analogs discontinuation, patients had a clinical relapse and retreatment regimen switches to TAF.
The protocol will be approved by Institutional Review Board (IRB) or Research ethic committee (REC) of each site and will be conducted in accordance with the principles of Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. Each patient provides written informed consent before enrollment.
Read the detailed description
Tenofovir alafenamide (TAF) is a new generation of oral antiviral drugs with similar antiviral activities to tenofovir disoproxil fumarate (TDF) and reduces the adverse effects of nephrotoxicity and bone mineral density reduction. This drug has already been reimbursed by National Health Insurance, and can be used for the treatment of patients with chronic hepatitis B.
This is a single-arm prospective clinical trial to enroll patients who discontinued entecavir (ETV) and tenofovir disoproxil fumarate (TDF) and experienced a clinical hepatitis flare up. They can be retreated with TAF for 48 weeks without postponing a 3-month observation period for alanine aminotransferase (ALT) level. The virological control, ALT level recovery, and changes in liver fibrosis, hepatitis B surface antigen, hepatitis B core-associated antigen, and renal function will be observed during retreatment. In addition, a group of patients with the same characteristics who received retreatment with entecavir or TDF will be collected as a control group for comparison. We believe this study can help us understand the clinical benefits of switching to TAF for retreatment after hepatitis flare in patients to discontinue oral antiviral agents.
- Conditions
- Chronic Hepatitis b, Hepatitis B Reactivation
- Being tested
- Vemlidy
- Keywords
- HBV,clinical relapse,Vemlidy (TAF)
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemlidyDrug
Also called Tenofovir Alafenamide (TAF)
25mg Tenofovir Alafenamide
| Study group | Role | What they receive |
|---|---|---|
| Switching therapy cohort | Experimental | single arm, open label Patients will receive Vemlidy (tenofovir alafenamide, TAF) 25mg, daily for 48 weeks Receives: Drug: Vemlidy |
| Historical continuing therapy cohort | No intervention | By retrospectively review medical records, The patients continued the original regimen (ETV, TDF) for retreatment (within 3.3 months of clinical relapse) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of virological remission (HBV DNA <20 IU/mL)
We will calculate the rate of virological remission (HBV DNA <20 IU/mL) after retreatment
Measured: 48 weeks
Secondary outcomes (4)
Rate of ALT normalization (ALT < 40 U/L) after retreatment
We will calculate the rate of ALT normalization (ALT < 40 U/L) after retreatment
Measured: 48 weeks
Rate of HBsAg change after retreatment compared with baseline
We will investigate the rate of HBsAg change after retreatment compared with the baseline HBsAg
Measured: 48 weeks
Rate of HBcrAg change after retreatment compared with baseline
We will investigate the rate of hepatitis B core-related antigen (HBcrAg) change after retreatment compared with baseline HBcrAg
Measured: 48 weeks
Rate of M2BPGi level change after retreatment compared with baseline
We will investigate the rate of Mac-2 binding protein glycosylation isomer (M2BPGi) level change after retreatment compared with baseline M2BPGi level
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start9 Sep 2020
- Primary completion1 Jan 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, Taipei City Hospital, Chiayi Christian Hospital, Dalin Tzu Chi General Hospital, E-DA Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, National Taiwan University Hospital Hsin-Chu Branch
- Responsible party
- Sponsor
- Investigators
- Tung-Hung Su, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496882
- Sponsor's protocol ID
- 201911095MIPD
- Acronym
- CHANGE
- Status last verified
- Feb 2026
- First submitted
- 26 Jul 2020
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Tenofovir Alafenamide-switching Therapy in Patients With Chronic Hepatitis B Experiencing Clinical Flare-up After Discontinuation of Nucleos[t]Ide Analogues Therapy
- ClinicalTrials.gov ID
- NCT04496882
- Acronym / sponsor ID
- CHANGE / 201911095MIPD
- Conditions
- Chronic Hepatitis b, Hepatitis B Reactivation
- Keywords
- HBV,clinical relapse,Vemlidy (TAF)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, Taipei City Hospital, Chiayi Christian Hospital, Dalin Tzu Chi General Hospital, E-DA Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, National Taiwan University Hospital Hsin-Chu Branch
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 2020 (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.
We will conduct a phase 4, multicenter, open-label trial at 8 academic centers in Taiwan.
Chronic hepatitis B patients receiving oral antiviral therapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF]) for at least 1 year, and fulfil the following nucleos(t)ide analogs discontinuation criteria. After nucleos(t)ide analogs discontinuation, patients had a clinical relapse and retreatment regimen switches to TAF.
The protocol will be approved by Institutional Review Board (IRB) or Research ethic committee (REC) of each site and will be conducted in accordance with the principles of Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. Each patient provides written informed consent before enrollment.
Detailed description
Tenofovir alafenamide (TAF) is a new generation of oral antiviral drugs with similar antiviral activities to tenofovir disoproxil fumarate (TDF) and reduces the adverse effects of nephrotoxicity and bone mineral density reduction. This drug has already been reimbursed by National Health Insurance, and can be used for the treatment of patients with chronic hepatitis B.
This is a single-arm prospective clinical trial to enroll patients who discontinued entecavir (ETV) and tenofovir disoproxil fumarate (TDF) and experienced a clinical hepatitis flare up. They can be retreated with TAF for 48 weeks without postponing a 3-month observation period for alanine aminotransferase (ALT) level. The virological control, ALT level recovery, and changes in liver fibrosis, hepatitis B surface antigen, hepatitis B core-associated antigen, and renal function will be observed during retreatment. In addition, a group of patients with the same characteristics who received retreatment with entecavir or TDF will be collected as a control group for comparison. We believe this study can help us understand the clinical benefits of switching to TAF for retreatment after hepatitis flare in patients to discontinue oral antiviral agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switching therapy cohort | Experimental | Drug: Vemlidysingle arm, open label Patients will receive Vemlidy (tenofovir alafenamide, TAF) 25mg, daily for 48 weeks |
| Historical continuing therapy cohort | No intervention | –By retrospectively review medical records, The patients continued the original regimen (ETV, TDF) for retreatment (within 3.3 months of clinical relapse) |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 1 years, and fulfil the following NUCs discontinuation criteria (1)HBeAg-positive patients achieved HBeAg loss, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieved virological remission (HBV DNA <20 IU/mL) for more than 1 year
- After NUC discontinuation, patients had a clinical relapse (HBV DNA > 2000 IU/mL, and ALT > 2x ULN)
- The retreatment regimen switches to TAF (within 3.3 months of clinical relapse)
- Historical continuing therapy cohort
- Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 1 years, and fulfil the following NUCs discontinuation criteria (1) HBeAg-positive patients achieved HBeAg loss, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieved virological remission (HBV DNA <20 IU/mL) for more than 1 year
Key exclusion criteria (4 listed)
- Patients who do not fulfill the discontinuation criteria
- Patients who have HCV, HDV or HIV co-infection
- Patients who discontinue lamivudine, adefovir, or telbivudine therapy
- Patients with liver cirrhosis by ultrasonography and clinical diagnosis
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 |
|---|---|---|
| VemlidyAlso: Tenofovir Alafenamide (TAF)25mg Tenofovir Alafenamide | Drug | Switching therapy cohort |
Primary outcome
Rate of virological remission (HBV DNA <20 IU/mL)
Time frame: 48 weeks
We will calculate the rate of virological remission (HBV DNA <20 IU/mL) after retreatment
4 secondary outcomes
Rate of ALT normalization (ALT < 40 U/L) after retreatment
Time frame: 48 weeks
Rate of HBsAg change after retreatment compared with baseline
Time frame: 48 weeks
Rate of HBcrAg change after retreatment compared with baseline
Time frame: 48 weeks
Rate of M2BPGi level change after retreatment compared with baseline
Time frame: 48 weeks
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 24 Feb 2026.
- 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.
Tung-Hung Su, MD, PhD principal investigator
National Taiwan University Hospital
8 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 Vemlidy in people with Chronic Hepatitis b and Hepatitis B Reactivation, run by National Taiwan University Hospital at 8 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 7 inclusion and 4 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Rate of virological remission (HBV DNA <20 IU/mL) (time frame: 48 weeks). 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 24 Feb 2026.