Chronic Hepatitis bNCT05793268
Finite Versus Continuous Nucleos(t)Ide Analogues for Chronic Hepatitis B
A study testing Nuc Discontinuation and Entecavir or Tenofovir in people with Chronic Hepatitis b, run by E-DA Hospital at 6 sites in Taiwan.
Trial summary
BACKGROUND: Finite nucleos(t)ide analogue (Nuc) therapy was proposed as an alternative strategy in the management of chronic hepatitis B (CHB) but there remained not data from randomized controlled trials to clarify safety and efficacy of this treatment strategy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- Nuc Discontinuation and Entecavir or Tenofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 6 sitesTaiwan
- Study dates
- 20 Dec 2022to Dec 2026
- Phase
- Interventional
- 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
- Age ≥ 20 years
- Chronic hepatitis B virus infection (defined as positive HBsAg for ≥ 6 months)
- Entecavir or tenofovir (either tenofovir disoproxil fumarate or tenofovir alafenamide) for at least two years and still on therapy at screening for this trial.
- Fulfillment of the stopping rules recommended by the Asian-Pacific guidelines 2016:
- For patients with positive HBeAg prior to their antiviral treatment, HBeAg seroconversion needs to be documented and followed by consolidation treatment for at least one year). Besides, serum ALT is within normal limits and HBV DNA is undetectable.
- For those with negative HBeAg prior to the antiviral therapy, undetectable HBV DNA documented on three separate occasions (at least 6 months apart)
- At screening for this study, HBsAg serology is positive, HBeAg negative, and HBV DNA undetectable in serum.
Who cannot join
- Liver cirrhosis (either clinical or pathological diagnosis) at screening
- Serious underlying disease (with valid certification of catastrophic illness) at screening
- Manifestations and concerns of hepatic decompensation, including serum bilirubin >2mg/dL and/or prolongation of prothrombin time > 3 seconds at screening
- Hepatitis C virus (if anti-HCV serology is positive, confirmation with detectable HCV RNA is required), human immunodeficiency virus (HIV) or hepatitis delta virus (HDV) coinfection at screening.
- Prior history of any malignancy including liver cancer
- Prior history of any organ transplantation
- Prior history of drug resistance to any Nuc agent
- Any patient condition that the treating physician deems inappropriate for enrollment in this trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Chia-Yi Christian Hospital
Chiayi City
E-Da Hospital
Kaohsiung City, 824
Taichung Veterans General Hospital
Taichung
Fu-Jen Catholic University Hospital
Taipei
Taitung Mackay Memorial Hospital
Taitung
Lotung Poh-Ai Hospital
Yilan
About this study
Official title: Safety and Efficacy of Finite Versus Continuous Nucleos(t)Ide Analogues Therapy in Patients With Chronic Hepatitis B: A Multicenter Randomized Controlled Trial
BACKGROUND:
Finite nucleos(t)ide analogue (Nuc) therapy was proposed as an alternative strategy in the management of chronic hepatitis B (CHB) but there remained not data from randomized controlled trials to clarify safety and efficacy of this treatment strategy.
Read more
AIMS:
The investigators aimed to evaluate the safety and efficacy of finite Nuc therapy versus continuous treatment in CHB patients without liver cirrhosis and also to identify factors that may predict therapeutic responses and clinical outcomes after withdrawal of Nuc treatment for CHB
MATERIAL AND METHODS:
This is a multicenter randomized controlled trial conducted in Taiwan. Eligible patients are adults (age≥20 years) with CHB (chronic infection ≥ 6 months) who fulfill the APASL guideline 2016 to stop NA therapy. Those with cirrhosis, malignancy, organ transplant, autoimmune disorder, or serious underlying diseases including renal impairment were excluded. A total of 360 patients will be enrolled. Enrolled patients are randomly allocated with a 1:1 ratio to continue viral suppression with entecavir (0.5mg once daily) or tenofovir disoproxil fumarate (300mg once daily) or stop the treatment. All patients will be followed up according to the protocol recommended by a panel of APASL experts. The primary analysis for study outcomes is scheduled at 3 years after randomization and the primary outcome is seroclearance of HBsAg. There will be interim analyses scheduled at one- and two-years following randomization of the first 200 patients, and also one-and two years following randomization of the planned 360 patients, to determine whether early termination of the trial may be justified by attainment of the efficacy endpoint (10% vs 1% of HBsAg seroclearance) or concerns of the safety outcomes (significant between-group difference in mortality, acute on chronic liver failure, or acute flares with hepatic decompensation).
Read the detailed description
Chronic hepatitis B virus (HBV) infection imposes a serious threat to global public health, affecting more than 250 million individuals around the world. In the management of patients with chronic hepatitis B (CHB), treatment with nucleos(t)ide analog (Nuc) has been shown to improve clinical outcomes including occurrence and recurrence of hepatocellular carcinoma (HCC), liver-related mortality, and overall mortality. Nuc therapy, however, cannot exterminate HBV and so continuous treatment is usually required to sustain viral inhibition. Seroclearance of hepatitis B surface antigen (HBsAg) predicts durable remission off Nuc and may serve as the treatment endpoint, but it rarely occurs with current regimen. Therefore, long-term to indefinite treatment is currently recommended.
In view of various concerns such as drug exposure, adherence, and expense for a treatment course that could be lifelong, a finite strategy of Nuc therapy was proposed to allow treatment withdrawal prior to HBsAg seroclearance. Another major reason for the finite strategy is a higher chance of HBsAg seroclearance following treatment cessation. Nevertheless, viral replication almost always reactivates and often leads to clinical flares. While an episode of acute flare might be self-limited or even conducive to HBsAg seroclearance, it could progress to acute on chronic liver failure with fatal consequences. Risks of these serious outcomes following treatment withdrawal need to be accurately quantified in order to inform the practice of finite Nuc therapy.
Existent literature on the efficacy and safety of finite Nuc therapy remained very limited, as recently shown in a systematic review and meta-analysis by Hall and colleagues. In order to close the gaps in current knowledge, the investigators conduct this multicenter randomized controlled trial to examine if cessation of Nuc is safe and conducive to HBsAg seroclearance.
- Conditions
- Chronic Hepatitis b
- Being tested
- Nuc Discontinuation, Entecavir or Tenofovir
- Keywords
- hepatitis b virus infection, antiviral therapy, randomized trial
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuc DiscontinuationOther
Eligible patients are randomly allocated with a 1:1 ratio to continue viral suppression or stop the treatment (entecavir or tenofovir). Patients will be followed up for 3 years. For patients who are assigned to the finite Nuc therapy, they should be monitored monthly for the initial 3 months and then every 3-6 months thereafter for relapse.
Entecavir or TenofovirDrug
Continuation of either entecavir or tenofovir treatment for 3 years
| Study group | Role | What they receive |
|---|---|---|
| Finite Therapy | Experimental | Discontinuation of nucleos(t)ide analog (Nuc) therapy Receives: Other: Nuc Discontinuation |
| Continuous Therapy | Active comparator | Continuation of oral Nuc monotherapy using entecavir (0.5mg/tab, once per day), tenofovir disoproxil fumarate (300mg/tab, once per day), or tenofovir alafenamide (25mg/tab, once per day) for 3 years Receives: Drug: Entecavir or Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with seroclearance of HBsAg
Serology of HBsAg was negative by the laboratory report
Measured: The time from randomization to seroclearance of HBsAg, up to 3 years after randomization
Secondary outcomes (12)
Number of Participants with liver-related mortality or liver transplantation
Death from liver failure or liver transplantation because of liver failure
Measured: The time from randomization to this secondary outcome, up to 3 years after randomization
Number of Participants with acute on chronic liver failure
According to the definition of Asian-Pacific Association for the Study of Liver Diseases
Measured: The time from randomization to this secondary outcome, up to 3 years after randomization
Number of Participants with severe acute exacerbation of chronic hepatitis B
Serum alanine aminotransferase > 5 times the upper limit of normal with either serum bilirubin ≥2mg/dL or prolongation of prothrombin time ≥3 seconds, in the presence of serum HBV DNA >2000 IU/mL
Measured: The time from randomization to this secondary outcome, up to 3 years after randomization
Number of Participants with clinical relapse of active hepatitis B
Serum alanine aminotransferase > 2 times the upper limit of normal in the presence of serum HBV DNA >2000 IU/mL
Measured: The time from randomization to this secondary outcome, up to 3 years after randomization
Number of Participants with incident hepatocellular carcinoma
Diagnosis of hepatocellular carcinoma after randomization
Measured: The time from randomization to this secondary outcome, up to 3 years after randomization
Changes in the FIB4 index from baseline
The formula for FIB-4 is: Age ([yr] x AST [U/L]) / ((PLT [10(9)/L]) x (ALT [U/L])(1/2)).
Measured: At three years after randomization
Changes in serum concentration of quantitative HBsAg from the baseline at randomization
Quantitative HBsAg measured in log IU/mL
Measured: At three years after randomization
Changes in serum concentration of HBcrAg from the baseline at randomization
Quantitative HBcrAg measured in log U/mL
Measured: At three years after randomization
Changes in the quality of life as measured by Short Form-36 Inventory from the baseline
Chinese version of the Short-form 36. Responses in each domain are transformed into a 0-100 scale, with a higher score indicating better health or functioning.
Measured: At each follow-up visit during the study period, up to 3 years after randomization
Changes in the scores measured by the General Anxiety Disorder-7 from baseline
Chinese version of the questionnaire. The total score can range from 0 to 21, with a higher score indicating more severe anxiety
Measured: At each follow-up visit during the study period, up to 3 years after randomization
Direct expenditure on healthcare
Money (measured in US dollars) that is paid for all sort of healthcare
Measured: At three years after randomization
Changes in the scores measured by the Perceived Stress Scale - 14 from baseline
Chinese version of the questionnaire. The total score can range from 0 to 56, with a higher score indicating a higher level of perceived stress.
Measured: At each follow-up visit during the study period, up to 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start20 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis bStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao-Chun Hsu, E-DA Hospital
- Investigators
- Yao-Chun Hsu, MD, PhD, Principal investigator, E-Da Hospital/I-Shou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793268
- Sponsor's protocol ID
- EMRP26111N
- Status last verified
- Mar 2023
- First submitted
- 19 Dec 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected during this trial, including de-identified individual participant data and data dictionaries defining fields in the datasets will be available to access. Documents that include the study protocol, statistical analysis plan, and informed consent form will also be available. Data access will be provided to investigators for academic research after a proposal has been approved by the study committee identified for this purpose. The investigator will sign a data access agreement on how to collaborate with consideration of potential overlaps between the proposal and ongoing efforts. Data will be available beginning with full publication of this Article. Proposals should be directed to the Principal Investigator (Dr. Yao-Chun Hsu), and the de-identified database will be transferred by email.
Publications
Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.
PubMed 26563120Kao JH, Jeng WJ, Ning Q, Su TH, Tseng TC, Ueno Y, Yuen MF. APASL guidance on stopping nucleos(t)ide analogues in chronic hepatitis B patients. Hepatol Int. 2021 Aug;15(4):833-851. doi: 10.1007/s12072-021-10223-5. Epub 2021 Jul 23.
PubMed 34297329Hsu YC, Yeh ML, Wong GL, Chen CH, Peng CY, Buti M, Enomoto M, Xie Q, Trinh H, Preda C, Liu L, Cheung KS, Yeo YH, Hoang J, Huang CF, Riveiro-Barciela M, Kozuka R, Istratescu D, Tsai PC, Accarino EV, Lee DH, Wu JL, Huang JF, Dai CY, Cheung R, Chuang WL, Yuen MF, Wong VW, Yu ML, Nguyen MH. Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B. J Infect Dis. 2021 Dec 1;224(11):1890-1899. doi: 10.1093/infdis/jiab241.
PubMed 33999179Berg T, Simon KG, Mauss S, Schott E, Heyne R, Klass DM, Eisenbach C, Welzel TM, Zachoval R, Felten G, Schulze-Zur-Wiesch J, Cornberg M, Op den Brouw ML, Jump B, Reiser H, Gallo L, Warger T, Petersen J; FINITE CHB study investigators [First investigation in stopping TDF treatment after long-term virological suppression in HBeAg-negative chronic hepatitis B]. Long-term response after stopping tenofovir disoproxil fumarate in non-cirrhotic HBeAg-negative patients - FINITE study. J Hepatol. 2017 Nov;67(5):918-924. doi: 10.1016/j.jhep.2017.07.012. Epub 2017 Jul 21.
PubMed 28736139Jeng WJ, Chen YC, Chien RN, Sheen IS, Liaw YF. Incidence and predictors of hepatitis B surface antigen seroclearance after cessation of nucleos(t)ide analogue therapy in hepatitis B e antigen-negative chronic hepatitis B. Hepatology. 2018 Aug;68(2):425-434. doi: 10.1002/hep.29640. Epub 2018 May 6.
PubMed 29108132Hall SAL, Vogrin S, Wawryk O, Burns GS, Visvanathan K, Sundararajan V, Thompson A. Discontinuation of nucleot(s)ide analogue therapy in HBeAg-negative chronic hepatitis B: a meta-analysis. Gut. 2022 Aug;71(8):1629-1641. doi: 10.1136/gutjnl-2020-323979. Epub 2021 Sep 7.
PubMed 34493592
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Finite Versus Continuous Nucleos(t)Ide Analogues Therapy in Patients With Chronic Hepatitis B: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05793268
- Acronym / sponsor ID
- EMRP26111N
- Conditions
- Chronic Hepatitis b
- Keywords
- hepatitis b virus infection, antiviral therapy, randomized trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Mar 2023 (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.
BACKGROUND:
Finite nucleos(t)ide analogue (Nuc) therapy was proposed as an alternative strategy in the management of chronic hepatitis B (CHB) but there remained not data from randomized controlled trials to clarify safety and efficacy of this treatment strategy.
AIMS:
The investigators aimed to evaluate the safety and efficacy of finite Nuc therapy versus continuous treatment in CHB patients without liver cirrhosis and also to identify factors that may predict therapeutic responses and clinical outcomes after withdrawal of Nuc treatment for CHB
MATERIAL AND METHODS:
This is a multicenter randomized controlled trial conducted in Taiwan. Eligible patients are adults (age≥20 years) with CHB (chronic infection ≥ 6 months) who fulfill the APASL guideline 2016 to stop NA therapy. Those with cirrhosis, malignancy, organ transplant, autoimmune disorder, or serious underlying diseases including renal impairment were excluded. A total of 360 patients will be enrolled. Enrolled patients are randomly allocated with a 1:1 ratio to continue viral suppression with entecavir (0.5mg once daily) or tenofovir disoproxil fumarate (300mg once daily) or stop the treatment. All patients will be followed up according to the protocol recommended by a panel of APASL experts. The primary analysis for study outcomes is scheduled at 3 years after randomization and the primary outcome is seroclearance of HBsAg. There will be interim analyses scheduled at one- and two-years following randomization of the first 200 patients, and also one-and two years following randomization of the planned 360 patients, to determine whether early termination of the trial may be justified by attainment of the efficacy endpoint (10% vs 1% of HBsAg seroclearance) or concerns of the safety outcomes (significant between-group difference in mortality, acute on chronic liver failure, or acute flares with hepatic decompensation).
Detailed description
Chronic hepatitis B virus (HBV) infection imposes a serious threat to global public health, affecting more than 250 million individuals around the world. In the management of patients with chronic hepatitis B (CHB), treatment with nucleos(t)ide analog (Nuc) has been shown to improve clinical outcomes including occurrence and recurrence of hepatocellular carcinoma (HCC), liver-related mortality, and overall mortality. Nuc therapy, however, cannot exterminate HBV and so continuous treatment is usually required to sustain viral inhibition. Seroclearance of hepatitis B surface antigen (HBsAg) predicts durable remission off Nuc and may serve as the treatment endpoint, but it rarely occurs with current regimen. Therefore, long-term to indefinite treatment is currently recommended.
In view of various concerns such as drug exposure, adherence, and expense for a treatment course that could be lifelong, a finite strategy of Nuc therapy was proposed to allow treatment withdrawal prior to HBsAg seroclearance. Another major reason for the finite strategy is a higher chance of HBsAg seroclearance following treatment cessation. Nevertheless, viral replication almost always reactivates and often leads to clinical flares. While an episode of acute flare might be self-limited or even conducive to HBsAg seroclearance, it could progress to acute on chronic liver failure with fatal consequences. Risks of these serious outcomes following treatment withdrawal need to be accurately quantified in order to inform the practice of finite Nuc therapy.
Existent literature on the efficacy and safety of finite Nuc therapy remained very limited, as recently shown in a systematic review and meta-analysis by Hall and colleagues. In order to close the gaps in current knowledge, the investigators conduct this multicenter randomized controlled trial to examine if cessation of Nuc is safe and conducive to HBsAg seroclearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finite Therapy | Experimental | Other: Nuc DiscontinuationDiscontinuation of nucleos(t)ide analog (Nuc) therapy |
| Continuous Therapy | Active comparator | Drug: Entecavir or TenofovirContinuation of oral Nuc monotherapy using entecavir (0.5mg/tab, once per day), tenofovir disoproxil fumarate (300mg/tab, once per day), or tenofovir alafenamide (25mg/tab, once per day) for 3 years |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 20 years
- Chronic hepatitis B virus infection (defined as positive HBsAg for ≥ 6 months)
- Entecavir or tenofovir (either tenofovir disoproxil fumarate or tenofovir alafenamide) for at least two years and still on therapy at screening for this trial.
- Fulfillment of the stopping rules recommended by the Asian-Pacific guidelines 2016:
- At screening for this study, HBsAg serology is positive, HBeAg negative, and HBV DNA undetectable in serum.
Key exclusion criteria (8 listed)
- Liver cirrhosis (either clinical or pathological diagnosis) at screening
- Serious underlying disease (with valid certification of catastrophic illness) at screening
- Manifestations and concerns of hepatic decompensation, including serum bilirubin >2mg/dL and/or prolongation of prothrombin time > 3 seconds at screening
- Hepatitis C virus (if anti-HCV serology is positive, confirmation with detectable HCV RNA is required), human immunodeficiency virus (HIV) or hepatitis delta virus (HDV) coinfection at screening.
- Prior history of any malignancy including liver cancer
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 |
|---|---|---|
| Nuc DiscontinuationEligible patients are randomly allocated with a 1:1 ratio to continue viral suppression or stop the treatment (entecavir or tenofovir). Patients will be followed up for 3 years. For patients who are assigned to the finite Nuc therapy, they should be monitored monthly for the initial 3 months and then every 3-6 months thereafter for relapse. | Other | Finite Therapy |
| Entecavir or TenofovirContinuation of either entecavir or tenofovir treatment for 3 years | Drug | Continuous Therapy |
Primary outcome
Number of Participants with seroclearance of HBsAg
Time frame: The time from randomization to seroclearance of HBsAg, up to 3 years after randomization
Serology of HBsAg was negative by the laboratory report
12 secondary outcomes
Number of Participants with liver-related mortality or liver transplantation
Time frame: The time from randomization to this secondary outcome, up to 3 years after randomization
Number of Participants with acute on chronic liver failure
Time frame: The time from randomization to this secondary outcome, up to 3 years after randomization
Number of Participants with severe acute exacerbation of chronic hepatitis B
Time frame: The time from randomization to this secondary outcome, up to 3 years after randomization
Number of Participants with clinical relapse of active hepatitis B
Time frame: The time from randomization to this secondary outcome, up to 3 years after randomization
Number of Participants with incident hepatocellular carcinoma
Time frame: The time from randomization to this secondary outcome, up to 3 years after randomization
Changes in the FIB4 index from baseline
Time frame: At three years after randomization
Changes in serum concentration of quantitative HBsAg from the baseline at randomization
Time frame: At three years after randomization
Changes in serum concentration of HBcrAg from the baseline at randomization
Time frame: At three years after randomization
Changes in the quality of life as measured by Short Form-36 Inventory from the baseline
Time frame: At each follow-up visit during the study period, up to 3 years after randomization
Changes in the scores measured by the General Anxiety Disorder-7 from baseline
Time frame: At each follow-up visit during the study period, up to 3 years after randomization
Direct expenditure on healthcare
Time frame: At three years after randomization
Changes in the scores measured by the Perceived Stress Scale - 14 from baseline
Time frame: At each follow-up visit during the study period, up to 3 years after randomization
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 31 Mar 2023.
- Background: PubMed 26563120Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.
- Background: PubMed 34297329Kao JH, Jeng WJ, Ning Q, Su TH, Tseng TC, Ueno Y, Yuen MF. APASL guidance on stopping nucleos(t)ide analogues in chronic hepatitis B patients. Hepatol Int. 2021 Aug;15(4):833-851. doi: 10.1007/s12072-021-10223-5. Epub 2021 Jul 23.
- Background: PubMed 33999179Hsu YC, Yeh ML, Wong GL, Chen CH, Peng CY, Buti M, Enomoto M, Xie Q, Trinh H, Preda C, Liu L, Cheung KS, Yeo YH, Hoang J, Huang CF, Riveiro-Barciela M, Kozuka R, Istratescu D, Tsai PC, Accarino EV, Lee DH, Wu JL, Huang JF, Dai CY, Cheung R, Chuang WL, Yuen MF, Wong VW, Yu ML, Nguyen MH. Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B. J Infect Dis. 2021 Dec 1;224(11):1890-1899. doi: 10.1093/infdis/jiab241.
- Background: PubMed 28736139Berg T, Simon KG, Mauss S, Schott E, Heyne R, Klass DM, Eisenbach C, Welzel TM, Zachoval R, Felten G, Schulze-Zur-Wiesch J, Cornberg M, Op den Brouw ML, Jump B, Reiser H, Gallo L, Warger T, Petersen J; FINITE CHB study investigators [First investigation in stopping TDF treatment after long-term virological suppression in HBeAg-negative chronic hepatitis B]. Long-term response after stopping tenofovir disoproxil fumarate in non-cirrhotic HBeAg-negative patients - FINITE study. J Hepatol. 2017 Nov;67(5):918-924. doi: 10.1016/j.jhep.2017.07.012. Epub 2017 Jul 21.
- Background: PubMed 29108132Jeng WJ, Chen YC, Chien RN, Sheen IS, Liaw YF. Incidence and predictors of hepatitis B surface antigen seroclearance after cessation of nucleos(t)ide analogue therapy in hepatitis B e antigen-negative chronic hepatitis B. Hepatology. 2018 Aug;68(2):425-434. doi: 10.1002/hep.29640. Epub 2018 May 6.
- Background: PubMed 34493592Hall SAL, Vogrin S, Wawryk O, Burns GS, Visvanathan K, Sundararajan V, Thompson A. Discontinuation of nucleot(s)ide analogue therapy in HBeAg-negative chronic hepatitis B: a meta-analysis. Gut. 2022 Aug;71(8):1629-1641. doi: 10.1136/gutjnl-2020-323979. Epub 2021 Sep 7.
- Individual participant dataSharing planned: Yes. Data collected during this trial, including de-identified individual participant data and data dictionaries defining fields in the datasets will be available to access. Documents that include the study protocol, statistical analysis plan, and informed consent form will also be available. Data access will be provided to investigators for academic research after a proposal has been approved by the study committee identified for this purpose. The investigator will sign a data access agreement on how to collaborate with consideration of potential overlaps between the proposal and ongoing efforts. Data will be available beginning with full publication of this Article. Proposals should be directed to the Principal Investigator (Dr. Yao-Chun Hsu), and the de-identified database will be transferred by email.
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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.
Yao-Chun Hsu, MD, PhD principal investigator
E-Da Hospital/I-Shou University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuc Discontinuation and Entecavir or Tenofovir in people with Chronic Hepatitis b, run by E-DA Hospital at 6 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 8 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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?
Number of Participants with seroclearance of HBsAg (time frame: The time from randomization to seroclearance of HBsAg, up to 3 years after randomization). 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 NCT05793268, which also lists 6 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 31 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.