Chronic Hepatitis BPhase 4NUC115132NCT01627223
Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation
A Phase 4 study testing Lamivudine and Entecavir in people with Chronic Hepatitis B, run by Taichung Veterans General Hospital at 8 sites in Taiwan.
Trial summary
This is a prospective, observational, open-label, 2-arm, parallel, multi-center study. Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI (such as lamivudine and entecavir) is medically recommended will be screened for eligibility. 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?
- Lamivudine and Entecavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 8 sitesTaiwan
- Study dates
- Jul 2012to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Male or female ≥ 20 years of age
- HBsAg carrier with spontaneously severe acute exacerbation for whom the treatment with nucleoside and nucleotide reverse transcriptase inhibitor (NRTI) such as lamivudine and entecavir is medically recommended
- Patients who fulfills all of the following criteria at screening:
- documented HBsAg positive for at least 6 months or anti-HBc IgM negative
- HBV DNA ≥ 2,000 IU/mL*
- The blood sample will be collected at screening visit, but this criterion will be checked after obtaining lab result. For patients fulfill all other criteria, they can be enrolled immediately.
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- total bilirubin ≥ 2 mg/dL or prolonged prothrombin time (PT) ≥ 3 sec
- serum ALT ≥ 10 x ULN
- Patient with sufficient renal function defined as SCr ≤ 1.5 x ULN or ClCr ≥ 50 mL/min
- Willing and able to sign a written informed consent
Who cannot join
- Female who is pregnant/lactating
- Patient with underlying liver cirrhosis classified as Child-Pugh class B or C
- Patients with documented hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) co-infection
- Patients with uncontrolled malignancy
- History or presence of alcohol or substance abuse within 1 year prior to the initiation of NRTI treatment
- History of hypersensitivity to any ingredient of observational drugs (Zeffix® or Baraclude®)
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- Current use of medicine which may induce hepatotoxicity
- Use of any antiviral therapy for HBV, such as interferon-α (IFN-α) and other nucleotide/nucleoside analogues, within 6 months prior to the initiation of NRTI treatment or exposure to any treatment for more than 3 months
- Use of any chemotherapy or immunosuppressive agents within 12 months prior to the initiation of NRTI treatment
- Use of any investigational product, including drug and invasive medical device, within 4 weeks prior to the initiation of NRTI treatment
- Patient with any medical or psychiatric condition, including the presence of significant abnormal laboratory values, which is considered not suitable for this study by investigator
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Changhua Christian Hospital
Changhua, Taiwan, 500
Chia-Yi Christian
Chiayi City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
China Medical University Hospital
Taichung, Taiwan, 40447
ChengChing Hospital
Taichung, Taiwan, 40764
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Tung's Taiching MetroHarbor Hospital
Taichung, Taiwan, 435
National Taiwan University Hospital Yu-Lin Branch
YuLin, Taiwan, 640
About this study
Official title: Comparison Between Lamivudine and Entecavir Treatment in Patients With Spontaneous Severe Acute Exacerbation of Chronic Hepatitis B.
This is a prospective, observational, open-label, 2-arm, parallel, multi-center study. Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI (such as lamivudine and entecavir) is medically recommended will be screened for eligibility. To target 74 evaluable subjects, approximately 82 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below.
- Cohort 1: Lamivudine 100 mg p.o. q.d.
- Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment.
The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29, 85, and 180 days after initiation of antiviral treatment. All assessments should be conducted based on routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be performed in the central lab. For patients who are willing to provide the residual samples of HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE will be followed until resolution or the event is considered stable.
Read the detailed description
The study is to compare treatment response of lamivudine and entecavir in patients with spontaneous severe acute exacerbation of chronic hepatitis B.
- Primary objective:
- To compare the overall survival (OS) rate during observational period between lamivudine and entecavir therapy.
- Secondary objectives:
- To compare the change from baseline in HBV DNA level at each visit between lamivudine and entecavir therapy.
- To compare the proportion of subjects who have a ≥ 2 log10 decline from baseline in HBV DNA level at each visit between lamivudine and entecavir therapy.
- To compare the change from baseline in ALT and AST level at each visit between lamivudine and entecavir therapy.
- To compare the proportion of subjects with prolonged prothrombin time (PT) at each visit between lamivudine and entecavir therapy.
- To compare the change from baseline in bilirubin level at each visit between lamivudine and entecavir therapy.
- To compare the transplantation-free survival rate during observational period between lamivudine and entecavir therapy.
- To assess the safety of lamivudine and entecavir treatments in patients with HBV-associated severe acute exacerbation.
Statistical method(s) for safety/efficacy evaluations:
- The major analysis will be performed according to the principal of intent-to-treat population; the safety evaluation will be performed according to the safety population.
- For primary endpoint, the time to event will be analyzed by Kaplan-Meier method and summarized as the number of observations, number of censored, median time point estimate and the 95% CI for median.
- Secondary efficacy endpoints:
- Change from baseline in HBV DNA level at each visit 2. Proportion of subjects with HBV DNA response* at each visit
- Defined as a ≥ 2 log10 decline from baseline HBV DNA level. 3. Change from baseline in ALT level at each visit 4. Change from baseline in AST level at each visit 5. Proportion of subjects with prolonged PT* at each visit
- PT at each visit will also be assessed. 6. Change from baseline in bilirubin level at each visit 7. Transplantation-free survival rate during observational period Continuous variables will be analyzed using two-sample t-test/ Wilcoxon Rank Sum test, and categorical variables will be analyzed Chi-squared/ Fishers' exact test. Descriptive statistics including mean, standard deviation, median, minimum, maximum, 95% confidence interval will be also presented. Categorical variables will be summarized by counts and percentage in frequency table. In addition, the time to event will be analyzed by Kaplan-Meier method. (4) The summary results of laboratory at the baseline and the end of study visit, the change from baseline to end of study visit will be summarized by descriptive statistics and paired t-test will be used under significant level 0.05. (5) Adverse events will be coded with MedDRA and a summary frequency table of adverse events will be provided. The severity and relationship to study medication of adverse events will be summarized as well. Furthermore, if any serious adverse event had occurred, the brief summary about serious adverse event will be described and listed in tables. (6) All statistical tests will be two-side and evaluated at the 0.05 level of significance.
- Conditions
- Chronic Hepatitis B
- Being tested
- Lamivudine, Entecavir
- Keywords
- Spontaneous Severe Acute Exacerbation of Chronic Hepatitis B, Lamivudine (Zeffix®), Entecavir (Baraclude®)
- 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.
LamivudineDrug
Also called Zeffix®
Lamivudine 100 mg p.o. q.d.
This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment.
EntecavirDrug
Also called Baraclude®
•Entecavir 0.5 mg p.o. q.d
This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine 100 mg p.o. q.d. | Experimental | To target 88 evaluable subjects, approximately 98 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below.
* Cohort 1: Lamivudine 100 mg p.o. q.d.
* Cohort 2: Entecavir 0.5 mg p.o. q.d.
This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment. Receives: Drug: Lamivudine |
| Entecavir 0.5 mg p.o. q.d | Experimental | To target 88 evaluable subjects, approximately 98 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below.
* Cohort 1: Lamivudine 100 mg p.o. q.d.
* Cohort 2: Entecavir 0.5 mg p.o. q.d.
This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment. Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HBV DNA level at each visit
To compare the change from baseline in HBV DNA level at each visit during observational period between lamivudine and entecavir therapy.
Measured: day 0、3、5、8±2、15±3、22±3、29±3、85±7、180±7
Secondary outcomes (7)
Overall survival (OS) rate during observational period
To compare the overall survival (OS) rate between lamivudine and entecavir therapy.
Measured: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3、85±7、180±7
Proportion of subjects with HBV DNA response at each visit
To compare the proportion of subjects who have a ≥ 2 log10 decline from baseline in HBV DNA level at each visit between lamivudine and entecavir therapy.
Measured: day 0、3、5、8±2、15±3、22±3、29±3、85±7、180±7
Change from baseline in ALT and AST level at each visit
To compare the change from baseline in ALT and AST level at each visit between lamivudine and entecavir therapy.
Measured: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3、85±7、180±7
Change from baseline in bilirubin level at each visit
To compare the change from baseline in bilirubin level at each visit between lamivudine and entecavir therapy.
Measured: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3、85±7、180±7
Proportion of subjects with prolonged PT at each visit
To compare the proportion of subjects with prolonged prothrombin time (PT) at each visit between lamivudine and entecavir therapy.
Measured: day 0、3、5、8±2、15±3、22±3、29±3、85±7、180±7
Transplantation-free survival rate during observational period
To compare the transplantation-free survival rate during observational period between lamivudine and entecavir therapy.
Measured: day 0、3、5、8±2、15±3、22±3、29±3、85±7、85±7、180±7
To assess the safety of lamivudine and entecavir treatments in patients with HBV-associated severe acute exacerbation.
- Change in laboratory data
- Adverse events
- Serious adverse events (SAE)
Measured: day 0 to day 180±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Slow progress in recruiting study patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Sheng-Shun Yang, Taichung Veterans General Hospital
- Investigators
- Sheng-Shun Yang, M.D., Principal investigator, Taichung Veterans General HospitalYu-Chun Hsu, M.D., Principal investigator, Changhua Christian HospitalShih-Jer Hsu, M.D., Principal investigator, National Taiwan University Hospital Yu-Lin BranchHsueh-Chou Lai, M.D., Principal investigator, China Medical University HospitalChun-Che Lin, M.D., Principal investigator, Chung Shan Medical UniversityJen-Chieh Huang, M.D., Principal investigator, ChengChing HospitalChi-Yi Chen, M.D., Principal investigator, Chia-Yi ChristianTsung-Ming Chen, M.D., Principal investigator, Tung's Taiching MetroHarbor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627223
- Sponsor's protocol ID
- NUC115132
- Acronym
- NUC115132
- Status last verified
- Oct 2016
- First submitted
- 18 Jun 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee TY, Chen CY, Lia HC, Hsu YC, Yang SS. The ultra-short virological dynamics in response to entecavir or lamivudine during chronic hepatitis B with spontaneous severe acute exacerbation. Antivir Ther. 2018;23(1):77-85. doi: 10.3851/IMP3183.
PubMed 28671553
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Lamivudine and Entecavir Treatment in Patients With Spontaneous Severe Acute Exacerbation of Chronic Hepatitis B.
- ClinicalTrials.gov ID
- NCT01627223
- Acronym / sponsor ID
- NUC115132 / NUC115132
- Conditions
- Chronic Hepatitis B
- Keywords
- Spontaneous Severe Acute Exacerbation of Chronic Hepatitis B, Lamivudine (Zeffix®), Entecavir (Baraclude®)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow progress in recruiting study patients
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Jun 2012 (estimated)
- 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 is a prospective, observational, open-label, 2-arm, parallel, multi-center study. Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI (such as lamivudine and entecavir) is medically recommended will be screened for eligibility. To target 74 evaluable subjects, approximately 82 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below.
- Cohort 1: Lamivudine 100 mg p.o. q.d.
- Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment.
The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29, 85, and 180 days after initiation of antiviral treatment. All assessments should be conducted based on routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be performed in the central lab. For patients who are willing to provide the residual samples of HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE will be followed until resolution or the event is considered stable.
Detailed description
The study is to compare treatment response of lamivudine and entecavir in patients with spontaneous severe acute exacerbation of chronic hepatitis B.
- Primary objective:
- To compare the overall survival (OS) rate during observational period between lamivudine and entecavir therapy.
- Secondary objectives:
- To compare the change from baseline in HBV DNA level at each visit between lamivudine and entecavir therapy.
- To compare the proportion of subjects who have a ≥ 2 log10 decline from baseline in HBV DNA level at each visit between lamivudine and entecavir therapy.
- To compare the change from baseline in ALT and AST level at each visit between lamivudine and entecavir therapy.
- To compare the proportion of subjects with prolonged prothrombin time (PT) at each visit between lamivudine and entecavir therapy.
- To compare the change from baseline in bilirubin level at each visit between lamivudine and entecavir therapy.
- To compare the transplantation-free survival rate during observational period between lamivudine and entecavir therapy.
- To assess the safety of lamivudine and entecavir treatments in patients with HBV-associated severe acute exacerbation.
Statistical method(s) for safety/efficacy evaluations:
- The major analysis will be performed according to the principal of intent-to-treat population; the safety evaluation will be performed according to the safety population.
- For primary endpoint, the time to event will be analyzed by Kaplan-Meier method and summarized as the number of observations, number of censored, median time point estimate and the 95% CI for median.
- Secondary efficacy endpoints:
- Change from baseline in HBV DNA level at each visit 2. Proportion of subjects with HBV DNA response* at each visit
- Defined as a ≥ 2 log10 decline from baseline HBV DNA level. 3. Change from baseline in ALT level at each visit 4. Change from baseline in AST level at each visit 5. Proportion of subjects with prolonged PT* at each visit
- PT at each visit will also be assessed. 6. Change from baseline in bilirubin level at each visit 7. Transplantation-free survival rate during observational period Continuous variables will be analyzed using two-sample t-test/ Wilcoxon Rank Sum test, and categorical variables will be analyzed Chi-squared/ Fishers' exact test. Descriptive statistics including mean, standard deviation, median, minimum, maximum, 95% confidence interval will be also presented. Categorical variables will be summarized by counts and percentage in frequency table. In addition, the time to event will be analyzed by Kaplan-Meier method. (4) The summary results of laboratory at the baseline and the end of study visit, the change from baseline to end of study visit will be summarized by descriptive statistics and paired t-test will be used under significant level 0.05. (5) Adverse events will be coded with MedDRA and a summary frequency table of adverse events will be provided. The severity and relationship to study medication of adverse events will be summarized as well. Furthermore, if any serious adverse event had occurred, the brief summary about serious adverse event will be described and listed in tables. (6) All statistical tests will be two-side and evaluated at the 0.05 level of significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamivudine 100 mg p.o. q.d. | Experimental | Drug: LamivudineTo target 88 evaluable subjects, approximately 98 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below. * Cohort 1: Lamivudine 100 mg p.o. q.d. * Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment. |
| Entecavir 0.5 mg p.o. q.d | Experimental | Drug: EntecavirTo target 88 evaluable subjects, approximately 98 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below. * Cohort 1: Lamivudine 100 mg p.o. q.d. * Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female ≥ 20 years of age
- HBsAg carrier with spontaneously severe acute exacerbation for whom the treatment with nucleoside and nucleotide reverse transcriptase inhibitor (NRTI) such as lamivudine and entecavir is medically recommended
- Patients who fulfills all of the following criteria at screening:
- Patient with sufficient renal function defined as SCr ≤ 1.5 x ULN or ClCr ≥ 50 mL/min
- Willing and able to sign a written informed consent
Key exclusion criteria (11 listed)
- Female who is pregnant/lactating
- Patient with underlying liver cirrhosis classified as Child-Pugh class B or C
- Patients with documented hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) co-infection
- Patients with uncontrolled malignancy
- History or presence of alcohol or substance abuse within 1 year prior to the initiation of NRTI treatment
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 |
|---|---|---|
| LamivudineAlso: Zeffix®Lamivudine 100 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment. | Drug | Lamivudine 100 mg p.o. q.d. |
| EntecavirAlso: Baraclude®•Entecavir 0.5 mg p.o. q.d This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment. | Drug | Entecavir 0.5 mg p.o. q.d |
Primary outcome
Change from baseline in HBV DNA level at each visit
Time frame: day 0、3、5、8±2、15±3、22±3、29±3、85±7、180±7
To compare the change from baseline in HBV DNA level at each visit during observational period between lamivudine and entecavir therapy.
7 secondary outcomes
Overall survival (OS) rate during observational period
Time frame: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3、85±7、180±7
Proportion of subjects with HBV DNA response at each visit
Time frame: day 0、3、5、8±2、15±3、22±3、29±3、85±7、180±7
Change from baseline in ALT and AST level at each visit
Time frame: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3、85±7、180±7
Change from baseline in bilirubin level at each visit
Time frame: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3、85±7、180±7
Proportion of subjects with prolonged PT at each visit
Time frame: day 0、3、5、8±2、15±3、22±3、29±3、85±7、180±7
Transplantation-free survival rate during observational period
Time frame: day 0、3、5、8±2、15±3、22±3、29±3、85±7、85±7、180±7
To assess the safety of lamivudine and entecavir treatments in patients with HBV-associated severe acute exacerbation.
Time frame: day 0 to day 180±7
Results and safety
The study was stopped early (reason given: Slow progress in recruiting study patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Derived from this study: PubMed 28671553Lee TY, Chen CY, Lia HC, Hsu YC, Yang SS. The ultra-short virological dynamics in response to entecavir or lamivudine during chronic hepatitis B with spontaneous severe acute exacerbation. Antivir Ther. 2018;23(1):77-85. doi: 10.3851/IMP3183.
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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.
Sheng-Shun Yang, M.D. principal investigator
Taichung Veterans General Hospital
Yu-Chun Hsu, M.D. principal investigator
Changhua Christian Hospital
Shih-Jer Hsu, M.D. principal investigator
National Taiwan University Hospital Yu-Lin Branch
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 Lamivudine and Entecavir in people with Chronic Hepatitis B, run by Taichung Veterans General 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Oct 2016. 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?
The study was stopped early (reason given: Slow progress in recruiting study patients). Results are not available in the source record.
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?
Change from baseline in HBV DNA level at each visit (time frame: day 0、3、5、8±2、15±3、22±3、29±3、85±7、180±7). 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 NCT01627223, which also lists 1 linked publication.
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 18 Oct 2016.