Virological BreakthroughNCT02582333
Clinical Course Study in Chronic Hepatitis B After Nucleos(t)Ide Analogue Therapy
An observational study of Virological Breakthrough and Prognosis, run by Taichung Veterans General Hospital at 4 sites in Taiwan.
Trial summary
Background: Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the leading causes of death in Taiwan for many years. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Virological Breakthrough, Prognosis
- What is being tested?
- Observation for clinical and virological changes
- How many people
- 347 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Oct 2015to 13 Mar 2021
- Phase
- Observational
- 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
Study population: Chronic hepatitis B patients who are indicated for stopping nucleos(t)ide analogue therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study
Who may be able to join
- Age > or = 20 years old
- Chronic hepatitis B patients who received tenofovir or entecavir as their first anti-HBV therapy
- Patients who have received nucleos(t)ide analogue therapy for > 3 years or reached the stopping criteria of APASL ( HBeAg+ patients: HBeAg seroconversion > 12 months; HBeAg - patients: HBV DNA undetectable > 12 months)
Who cannot join
- History of liver cirrhosis or hepatocellular carcinoma
- Recipients of liver transplantation
- Concurrent malignancies (except curable skin cancers)
- Concomitant use of immunosuppressants
- Coinfection with HCV, HDV, HIV
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Show Chwan Memorial Hospital
Changhua
Cheng Ching General Hospital-Chung Kang Branch
Taichung, 40705
Chung Shan Medical University Hospital
Taichung, 40705
Taichung Veterans General Hospital
Taichung, 40705
About this study
Background:
Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998, and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high viral load in a maximum duration of three years. However, there is a significant proportion of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current knowledge, in what conditions that the NA therapy can be successfully discontinued without hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate the clinical and virological changes of CHB patients after stopping NA therapy, and finding the prognostic indicators may be an important basis for stopping NA therapy in CHB patients in the future.
Read more
Objectives:
- To access the clinical and virological changes after stopping NA therapy
- To determine important prognostic indicators for stopping NA therapy
Methods:
In this prospective cohort study, the investigators plan to recruit CHB patients who are indicated for stopping NA therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study, and clinical and virological data will be collected during routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed according the following data:
- Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history.
- Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis flare in the first 2 years after stopping NA therapy, liver function and virological status tests will be conducted for analysis.
Read the detailed description
Background:
Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998, and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high viral load in a maximum duration of three years. However, there is a significant proportion of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current knowledge, in what conditions that the NA therapy can be successfully discontinued without hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate the clinical and virological changes of CHB patients after stopping NA therapy, and finding the prognostic indicators may be an important basis for stopping NA therapy in CHB patients in the future.
Objectives:
- To access the clinical and virological changes after stopping NA therapy
- To determine important prognostic indicators for stopping NA therapy
Methods:
In this prospective cohort study, the investigators plan to recruit CHB patients who are indicated for stopping NA therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study, and clinical and virological data will be collected during routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed according the following data:
- Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history.
- Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis flare in the first 2 years after stopping NA therapy, liver function and virological status tests will be conducted for analysis.
Importance:
To clinicians in treating chronic hepatitis B, this study will provide important data regarding the clinical courses after stopping NA therapy, and important prognostic indicators may be determined. These findings could help clinicians in decision making for discontinuation of NA therapy and booking follow-up schedules. To basic scientists, this study will provide the virological changes after stopping NA therapy, and these findings may help developing further virological researches.
- Conditions
- Virological Breakthrough, Prognosis
- Being tested
- Observation for clinical and virological changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation for clinical and virological changesOther
Only observation after stopping nucleos(t)ide analogue
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir | Chronic hepatitis B patients who receive tenofovir as their first anti-HBV therapy and are indicated for stopping tenofovir therapy Receives: Other: Observation for clinical and virological changes | |
| Entecavir | Chronic hepatitis B patients who receive entecavir as their first anti-HBV therapy and are indicated for stopping entecavir therapy Receives: Other: Observation for clinical and virological changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg seroconversion
HBsAg negative, anti-HBs positive
Measured: 2 years after stopping nucleos(t)ide analogue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Oct 2020
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virological BreakthroughStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teng-Yu Lee, Taichung Veterans General Hospital
- Investigators
- Teng-Yu Lee, MD, PhD, Study chair, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582333
- Sponsor's protocol ID
- CF15240B
- Status last verified
- Mar 2021
- First submitted
- 20 Oct 2015
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course Study in Chronic Hepatitis B After Nucleos(t)Ide Analogue Therapy
- ClinicalTrials.gov ID
- NCT02582333
- Acronym / sponsor ID
- CF15240B
- Conditions
- Virological Breakthrough, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 21 Oct 2015 (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.
Background:
Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998, and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high viral load in a maximum duration of three years. However, there is a significant proportion of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current knowledge, in what conditions that the NA therapy can be successfully discontinued without hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate the clinical and virological changes of CHB patients after stopping NA therapy, and finding the prognostic indicators may be an important basis for stopping NA therapy in CHB patients in the future.
Objectives:
- To access the clinical and virological changes after stopping NA therapy
- To determine important prognostic indicators for stopping NA therapy
Methods:
In this prospective cohort study, the investigators plan to recruit CHB patients who are indicated for stopping NA therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study, and clinical and virological data will be collected during routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed according the following data:
- Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history.
- Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis flare in the first 2 years after stopping NA therapy, liver function and virological status tests will be conducted for analysis.
Detailed description
Background:
Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998, and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high viral load in a maximum duration of three years. However, there is a significant proportion of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current knowledge, in what conditions that the NA therapy can be successfully discontinued without hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate the clinical and virological changes of CHB patients after stopping NA therapy, and finding the prognostic indicators may be an important basis for stopping NA therapy in CHB patients in the future.
Objectives:
- To access the clinical and virological changes after stopping NA therapy
- To determine important prognostic indicators for stopping NA therapy
Methods:
In this prospective cohort study, the investigators plan to recruit CHB patients who are indicated for stopping NA therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study, and clinical and virological data will be collected during routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed according the following data:
- Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history.
- Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis flare in the first 2 years after stopping NA therapy, liver function and virological status tests will be conducted for analysis.
Importance:
To clinicians in treating chronic hepatitis B, this study will provide important data regarding the clinical courses after stopping NA therapy, and important prognostic indicators may be determined. These findings could help clinicians in decision making for discontinuation of NA therapy and booking follow-up schedules. To basic scientists, this study will provide the virological changes after stopping NA therapy, and these findings may help developing further virological researches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir | – | Other: Observation for clinical and virological changesChronic hepatitis B patients who receive tenofovir as their first anti-HBV therapy and are indicated for stopping tenofovir therapy |
| Entecavir | – | Other: Observation for clinical and virological changesChronic hepatitis B patients who receive entecavir as their first anti-HBV therapy and are indicated for stopping entecavir therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis B patients who are indicated for stopping nucleos(t)ide analogue therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study
Key inclusion criteria (3 listed)
- Age > or = 20 years old
- Chronic hepatitis B patients who received tenofovir or entecavir as their first anti-HBV therapy
- Patients who have received nucleos(t)ide analogue therapy for > 3 years or reached the stopping criteria of APASL ( HBeAg+ patients: HBeAg seroconversion > 12 months; HBeAg - patients: HBV DNA undetectable > 12 months)
Key exclusion criteria (5 listed)
- History of liver cirrhosis or hepatocellular carcinoma
- Recipients of liver transplantation
- Concurrent malignancies (except curable skin cancers)
- Concomitant use of immunosuppressants
- Coinfection with HCV, HDV, HIV
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 |
|---|---|---|
| Observation for clinical and virological changesOnly observation after stopping nucleos(t)ide analogue | Other | Entecavir, Tenofovir |
Primary outcome
HBsAg seroconversion
Time frame: 2 years after stopping nucleos(t)ide analogue
HBsAg negative, anti-HBs positive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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 study chair
Taichung Veterans General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Virological Breakthrough and Prognosis, run by Taichung Veterans General Hospital at 4 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 3 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: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HBsAg seroconversion (time frame: 2 years after stopping nucleos(t)ide analogue). 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 16 Mar 2021.