Hepatitis B, ChronicNCT06550622
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
An observational study of Hepatitis B, Chronic, run by Huashan Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 10 Aug 2027
- 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: The subject studied were HBsAg-negative, HBeAg-negative, and anti-HBe positive patients with chronic hepatitis B
Who may be able to join
- HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative;
- Having serum specimens retained at baseline and at 48 weeks off treatment follow up;
- Being willing to follow up regularly for 1 year.
Who cannot join
- Patients with hepatitis B cirrhosis in the compensated and decompensated stages: this includes patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 prior to NUC treatment, or who have had complications of the decompensated stage of cirrhosis, such as ascites, hepatic encephalopathy, or ruptured oesophago-gastric fundal varices bleeding;
- Combined HAV, HCV, HDV, HEV, HIV infections, alcoholic liver disease, inherited metabolic liver disease, pharmacological liver disease, non-alcoholic fatty liver disease, autoimmune liver disease and other chronic liver diseases;
- Primary hepatocellular carcinoma or those with AFP greater than 100 ng/ml at screening and imaging suggestive of possible malignant hepatic occupancy; or patients with AFP greater than 100 ng/ml for a sustained period of 3 months;
- Patients with a combination of other malignant tumours (excluding those who have been cured);
- Patients with severe diseases or uncontrolled disease
- Those who are also participating in other clinical studies;
- Patients deemed unsuitable by the investigator to participate in this study.
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
Fahong Li
Shanghai, Shanghai Municipality, 200040
Fahong Li, 13524212580, minelihong@163.com
About this study
Official title: Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion
The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay.
The main question it aims to answer is:
What's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU/ml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU/ml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.
Read the detailed description
In this study, chronic hepatitis B patients who achieved HBsAg loss by current ARCHITECT HBsAg testing (lower limit of detection for HBsAg is 0.05 IU/ml) under interferon therapy and received consolidation therapy for 3 month after that were screened for eligibility. Those who are willing to discontinue were enrolled in the study. Patients were divided in two groups according to HBsAg levels，one with patients who were HBsAg-negative （HBsAg<0.005 IU/mL）by HBsAg next assay , and the other with patients who had HBsAg levels between 0.005 IU/mL and 0.05IU/mL. Patients were followed up for 48 weeks after discontinuation after HBsAg loss and HBsAg reversion rates in the two groups were analyzed and compared.
- Conditions
- Hepatitis B, Chronic
- Keywords
- HBsAg next assay, Functional cure, HBsAg loss, HBsAg reversion
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | CHB patients with HBsAg level<0.005 IU/mL | |
| Group B | CHB patients with 0.005 IU/mL< HBsAg level < 0.05 IU/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg reversion rate
HBsAg reversion rate in patients with HBsAg loss by Abbott's HBsAg next assay at week 48 off treatment
Measured: 48 weeks
Secondary outcomes (4)
Proportion of patients who were HBsAg positive
Proportion of patients who were HBsAg positive by HBsAg Next assay in those who were HBsAg negative by ARCHITECT HBsAg test.
Measured: 48 weeks
HBsAg seroconversion rate
HBsAg seroconversion rate at 48 weeks off treatment follow-up in patients with HBsAg loss
Measured: 48 weeks
Surface antibody disappearing rates
Surface antibody disappearing rates at 48 Weeks off treatment Follow-up in Patients with HBsAg loss
Measured: 48 weeks
Viral reactivation rate
Viral reactivation rate (HBV DNA > 20 IU/ml) at 48 weeks off treatment in patients with HBsAg loss
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiming Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550622
- Sponsor's protocol ID
- 2024-700
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion
- ClinicalTrials.gov ID
- NCT06550622
- Acronym / sponsor ID
- 2024-700
- Conditions
- Hepatitis B, Chronic
- Keywords
- HBsAg next assay, Functional cure, HBsAg loss, HBsAg reversion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 13 Aug 2024 (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 learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay.
The main question it aims to answer is:
What's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU/ml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU/ml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.
Detailed description
In this study, chronic hepatitis B patients who achieved HBsAg loss by current ARCHITECT HBsAg testing (lower limit of detection for HBsAg is 0.05 IU/ml) under interferon therapy and received consolidation therapy for 3 month after that were screened for eligibility. Those who are willing to discontinue were enrolled in the study. Patients were divided in two groups according to HBsAg levels，one with patients who were HBsAg-negative （HBsAg<0.005 IU/mL）by HBsAg next assay , and the other with patients who had HBsAg levels between 0.005 IU/mL and 0.05IU/mL. Patients were followed up for 48 weeks after discontinuation after HBsAg loss and HBsAg reversion rates in the two groups were analyzed and compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –CHB patients with HBsAg level<0.005 IU/mL |
| Group B | – | –CHB patients with 0.005 IU/mL< HBsAg level < 0.05 IU/mL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject studied were HBsAg-negative, HBeAg-negative, and anti-HBe positive patients with chronic hepatitis B
Key inclusion criteria (3 listed)
- HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative;
- Having serum specimens retained at baseline and at 48 weeks off treatment follow up;
- Being willing to follow up regularly for 1 year.
Key exclusion criteria (7 listed)
- Patients with hepatitis B cirrhosis in the compensated and decompensated stages: this includes patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 prior to NUC treatment, or who have had complications of the decompensated stage of cirrhosis, such as ascites, hepatic encephalopathy, or ruptured oesophago-gastric fundal varices bleeding;
- Combined HAV, HCV, HDV, HEV, HIV infections, alcoholic liver disease, inherited metabolic liver disease, pharmacological liver disease, non-alcoholic fatty liver disease, autoimmune liver disease and other chronic liver diseases;
- Primary hepatocellular carcinoma or those with AFP greater than 100 ng/ml at screening and imaging suggestive of possible malignant hepatic occupancy; or patients with AFP greater than 100 ng/ml for a sustained period of 3 months;
- Patients with a combination of other malignant tumours (excluding those who have been cured);
- Patients with severe diseases or uncontrolled disease
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
HBsAg reversion rate
Time frame: 48 weeks
HBsAg reversion rate in patients with HBsAg loss by Abbott's HBsAg next assay at week 48 off treatment
4 secondary outcomes
Proportion of patients who were HBsAg positive
Time frame: 48 weeks
HBsAg seroconversion rate
Time frame: 48 weeks
Surface antibody disappearing rates
Time frame: 48 weeks
Viral reactivation rate
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- 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.
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, Chronic, run by Huashan Hospital 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 3 inclusion and 7 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 13 Aug 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 Fahong Li (13524212580, minelihong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg reversion rate (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.