Hepatitis BNCT05977283
HBsAg Declined Patients Follow-up Study
An observational study of Hepatitis B and Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The goal of this observational study is to prospectively follow chronic hepatitis B patients who had HBsAg decline in the past 12 months prior to screening. The main question it aims to answer are: Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Hepatitis B, Chronic
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2023to Mar 2028
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 12 months prior to screening due to any reason (with or without new molecular entities therapy). Among the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3 log10 IU/mL.
Who may be able to join
- Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 12 months prior to screening due to any reason (with or without new molecular entities therapy). Among the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3 log10 IU/mL.
- Able and willing to provide written informed consent and to comply with the study protocol according to International Council for Harmonization (ICH) and local regulations.
Who cannot join
- Any condition which, in the opinion of the investigator, contraindicates their participant in this study.
- Participants who are currently participating in interventional clinical study exploring HBV treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510000
Xier Liang, MD, +8662787432, freeliang@163.com
About this study
Official title: An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months
The goal of this observational study is to prospectively follow chronic hepatitis B patients who had HBsAg decline in the past 12 months prior to screening. The main question it aims to answer are:
- Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months due to any reason (with or without new molecular entities therapy).
Participants will be followed up for 36 months after enrollment and may be extended upon expiration according to study objectives.
Read the detailed description
This study is a retrospective and prospective follow-up study for participants who had HBsAg decline in past 6 months due to any reason (with or without new molecular entities therapy). The follow-up period will be 3 years (36 months after enrollment) and may be extended upon expiration according to study objectives. Patients are treated or untreated based on current clinical practice guidelines, and every medical decision and course of treatment will reflect exclusively the decision of the treating physician in a routine clinical situation. The conduct of this non-interventional follow-up study and its documentation procedures will not affect the routine treatment of the subjects. It is only requested that any medical decisions, procedures and data during this study be documented in the electronic case report/record form (eCRF) according to the study protocol as available from routine medical care. Diagnostic testing and monitoring procedures are exclusively based on the decision of the treating physician.
In general, patients with hepatitis B should be monitored at least twice a year (every 6 months), every 12 weeks during NUC therapy and every 2 to 4 weeks during interferon-α therapy in accordance with clinical needs (Table 3-1 and Table 3-2). For patients had HBsAg decline in past 6 months due to new molecular entities therapy, The baseline of this follow-up study is the time when NME discontinued (within 28 days of the last does of NME or within 2 half-life period of the NME). For patients had HBsAg decline in past 6 months without new molecular entities therapy, the baseline should be the time of enrolling in the study. The time of enrolling in this study may be posterior or equal to baseline, which is not necessarily the baseline of this study. The visit window period is ±28 days for patients with NUC therapy and ±7 days for patients with interferon-α therapy. Follow-up study visit data can be collected retrospectively if it has been performed before entry of this study.
Medical decisions, procedures and data before this follow-up study will also be documented if available. Participants will be asked to store a certain amount of blood samples in site during study visit for future HBV markers, host immunity or other related tests. The retained remaining samples from previous tests before this follow-up study may also be used for HBV related exploratory research after patient informed consent.
- Conditions
- Hepatitis B, Hepatitis B, Chronic
- Keywords
- chronic hepatitis b, HBsAg, functional cure
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with HBsAg loss (<0.05 IU/ml) at 12 months
Describe treatment pattern and its impact on HBsAg loss of the included patients (with or without new molecular entities therapy) by the proportion of participants with HBsAg loss at week 48.
Measured: at week 48
Secondary outcomes (5)
Proportion of participants with HBsAg loss or HBsAg seroconversion.
HBsAg loss / seroconversion at each study visit
Measured: at week 48, 96 and 144
Change from baseline in quantitative HBsAg levels over time
including but not limited to actual values and changes from Baseline (Pre-treatment, 6 month prior to screening, and the beginning of follow-up study) at week 48, 96 and 144 in HBsAg, HBV DNA, HBeAg, HBcrAg, HBV RNA level
Measured: at week 48, 96 and 144
Change from baseline in quantitative anti-HBs levels over time
Describe the development of anti-HBs over time for hepatitis B patients with HBsAg decline in past 6 months due to any reason (with or without new molecular entities therapy)
Measured: at week 48, 96 and 144
Incidence of liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality, at each study visit
The incidence of de novo liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality
Measured: at week 48, 96 and 144
The change of Health-related quality-of-life (HRQoL) over time
evaluated the risk factors on the progression of CHB, by the available data
Measured: at week 48, 96 and 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start11 May 2023
- Primary completionJun 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jinlin hou, Master, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977283
- Sponsor's protocol ID
- NFEC-2022-260
- Status last verified
- Feb 2024
- First submitted
- 29 Nov 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
BLUMBERG BS, ALTER HJ, VISNICH S. A "NEW" ANTIGEN IN LEUKEMIA SERA. JAMA. 1965 Feb 15;191:541-6. doi: 10.1001/jama.1965.03080070025007. No abstract available.
PubMed 14239025European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
PubMed 28427875Brunetto MR. A new role for an old marker, HBsAg. J Hepatol. 2010 Apr;52(4):475-7. doi: 10.1016/j.jhep.2009.12.020. Epub 2010 Jan 30. No abstract available.
PubMed 20185190Chan HL, Thompson A, Martinot-Peignoux M, Piratvisuth T, Cornberg M, Brunetto MR, Tillmann HL, Kao JH, Jia JD, Wedemeyer H, Locarnini S, Janssen HL, Marcellin P. Hepatitis B surface antigen quantification: why and how to use it in 2011 - a core group report. J Hepatol. 2011 Nov;55(5):1121-31. doi: 10.1016/j.jhep.2011.06.006. Epub 2011 Jun 28.
PubMed 21718667- Lau G K K, Marcellin P, Brunetto M, et al. 917 on-treatment monitoring of HBsAg levels to predict response to peginterferon alfa-2a in patients with HBeAg-positive chronic hepatitis B[J]. Journal of Hepatology, 2009, 50, Supplement 1(0): S333
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months
- ClinicalTrials.gov ID
- NCT05977283
- Acronym / sponsor ID
- NFEC-2022-260
- Conditions
- Hepatitis B, Hepatitis B, Chronic
- Keywords
- chronic hepatitis b, HBsAg, functional cure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 Aug 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.
The goal of this observational study is to prospectively follow chronic hepatitis B patients who had HBsAg decline in the past 12 months prior to screening. The main question it aims to answer are:
- Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months due to any reason (with or without new molecular entities therapy).
Participants will be followed up for 36 months after enrollment and may be extended upon expiration according to study objectives.
Detailed description
This study is a retrospective and prospective follow-up study for participants who had HBsAg decline in past 6 months due to any reason (with or without new molecular entities therapy). The follow-up period will be 3 years (36 months after enrollment) and may be extended upon expiration according to study objectives. Patients are treated or untreated based on current clinical practice guidelines, and every medical decision and course of treatment will reflect exclusively the decision of the treating physician in a routine clinical situation. The conduct of this non-interventional follow-up study and its documentation procedures will not affect the routine treatment of the subjects. It is only requested that any medical decisions, procedures and data during this study be documented in the electronic case report/record form (eCRF) according to the study protocol as available from routine medical care. Diagnostic testing and monitoring procedures are exclusively based on the decision of the treating physician.
In general, patients with hepatitis B should be monitored at least twice a year (every 6 months), every 12 weeks during NUC therapy and every 2 to 4 weeks during interferon-α therapy in accordance with clinical needs (Table 3-1 and Table 3-2). For patients had HBsAg decline in past 6 months due to new molecular entities therapy, The baseline of this follow-up study is the time when NME discontinued (within 28 days of the last does of NME or within 2 half-life period of the NME). For patients had HBsAg decline in past 6 months without new molecular entities therapy, the baseline should be the time of enrolling in the study. The time of enrolling in this study may be posterior or equal to baseline, which is not necessarily the baseline of this study. The visit window period is ±28 days for patients with NUC therapy and ±7 days for patients with interferon-α therapy. Follow-up study visit data can be collected retrospectively if it has been performed before entry of this study.
Medical decisions, procedures and data before this follow-up study will also be documented if available. Participants will be asked to store a certain amount of blood samples in site during study visit for future HBV markers, host immunity or other related tests. The retained remaining samples from previous tests before this follow-up study may also be used for HBV related exploratory research after patient informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 12 months prior to screening due to any reason (with or without new molecular entities therapy). Among the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3 log10 IU/mL.
Key inclusion criteria (2 listed)
- Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 12 months prior to screening due to any reason (with or without new molecular entities therapy). Among the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3 log10 IU/mL.
- Able and willing to provide written informed consent and to comply with the study protocol according to International Council for Harmonization (ICH) and local regulations.
Key exclusion criteria (2 listed)
- Any condition which, in the opinion of the investigator, contraindicates their participant in this study.
- Participants who are currently participating in interventional clinical study exploring HBV treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with HBsAg loss (<0.05 IU/ml) at 12 months
Time frame: at week 48
Describe treatment pattern and its impact on HBsAg loss of the included patients (with or without new molecular entities therapy) by the proportion of participants with HBsAg loss at week 48.
5 secondary outcomes
Proportion of participants with HBsAg loss or HBsAg seroconversion.
Time frame: at week 48, 96 and 144
Change from baseline in quantitative HBsAg levels over time
Time frame: at week 48, 96 and 144
Change from baseline in quantitative anti-HBs levels over time
Time frame: at week 48, 96 and 144
Incidence of liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality, at each study visit
Time frame: at week 48, 96 and 144
The change of Health-related quality-of-life (HRQoL) over time
Time frame: at week 48, 96 and 144
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 14239025BLUMBERG BS, ALTER HJ, VISNICH S. A "NEW" ANTIGEN IN LEUKEMIA SERA. JAMA. 1965 Feb 15;191:541-6. doi: 10.1001/jama.1965.03080070025007. No abstract available.
- Background: PubMed 28427875European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
- Background: PubMed 20185190Brunetto MR. A new role for an old marker, HBsAg. J Hepatol. 2010 Apr;52(4):475-7. doi: 10.1016/j.jhep.2009.12.020. Epub 2010 Jan 30. No abstract available.
- Background: PubMed 21718667Chan HL, Thompson A, Martinot-Peignoux M, Piratvisuth T, Cornberg M, Brunetto MR, Tillmann HL, Kao JH, Jia JD, Wedemeyer H, Locarnini S, Janssen HL, Marcellin P. Hepatitis B surface antigen quantification: why and how to use it in 2011 - a core group report. J Hepatol. 2011 Nov;55(5):1121-31. doi: 10.1016/j.jhep.2011.06.006. Epub 2011 Jun 28.
- Background- Lau G K K, Marcellin P, Brunetto M, et al. 917 on-treatment monitoring of HBsAg levels to predict response to peginterferon alfa-2a in patients with HBeAg-positive chronic hepatitis B[J]. Journal of Hepatology, 2009, 50, Supplement 1(0): S333
- Individual participant dataSharing planned: Undecided
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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.
jinlin hou, Master principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Xieer Liang, M.D. (+862062787432, freeliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with HBsAg loss (<0.05 IU/ml) at 12 months (time frame: at week 48). 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 NCT05977283, which also lists 5 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 20 Feb 2024.