Chronic Hepaititis BEarly Phase 1NCT07328711
Immunomodulatory Therapy and Predictors of Clinical Cure in Chronic Hepatitis B
A Early Phase 1 study testing Hepatitis B Immunoglobulin (HBIg) in people with Chronic Hepaititis B, run by Peking University People's Hospital at 1 site in China.
Trial summary
Achieving clinical cure, defined as hepatitis B surface antigen (HBsAg) seroclearance, represents a major research focus and an ideal therapeutic goal for chronic hepatitis B (CHB). A significant challenge in CHB management lies in promoting clinical cure, reducing relapse, and progressing towards complete cure. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepaititis B
- What is being tested?
- Hepatitis B Immunoglobulin (HBIg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 60 years (inclusive).
- Documented HBsAg and/or HBV DNA positivity for over 6 months.
- Achieved HBsAg seroclearance (<0.05 IU/mL) following a PegIFNα-based treatment regimen.
- HBeAg negative and HBV DNA <10 IU/mL.
- Good compliance and willingness to voluntarily sign the informed consent form.
Who cannot join
- Current decompensated cirrhosis or a history of decompensated cirrhosis.
- Individuals with spontaneous or Nucleos(t)ide analogue-induced HBsAg seroclearance.
- Coinfection with other viruses, such as hepatitis A, C, D, E viruses, or human immunodeficiency virus (HIV).
- Severe concurrent physical or mental illnesses other than hepatitis B, including uncontrolled primary renal, cardiac, pulmonary, vascular, neurological, digestive, or severe metabolic diseases (e.g., uncontrolled hyperthyroidism, severe diabetic complications, adrenal disorders), immunodeficiency diseases, or severe infections; active or suspected malignancy, or a history of malignancy.
- Use of corticosteroids, immunosuppressants, or chemotherapeutic agents within the 6 months prior to enrollment or at present.
- Concurrent other liver diseases such as alcoholic liver disease or autoimmune liver disease.
- Body Mass Index (BMI) > 28 kg/m².
- Any other condition considered by the investigator to potentially compromise patient compliance or otherwise make the patient unsuitable for participation in the 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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Wenhui Ren, 010-88324516, rmkyc@163.com
About this study
Official title: Study on Novel Immunomodulatory Therapeutic Regimens for Clinical Cure of Chronic Hepatitis B and Efficacy Prediction
Achieving clinical cure, defined as hepatitis B surface antigen (HBsAg) seroclearance, represents a major research focus and an ideal therapeutic goal for chronic hepatitis B (CHB). A significant challenge in CHB management lies in promoting clinical cure, reducing relapse, and progressing towards complete cure. Studies have found that in patients who achieve HBsAg seroclearance following peginterferon alfa (PegIFNα) therapy, the seroconversion of anti-HBs and its attainment to a certain level are crucial for minimizing relapse. Strategies to promote anti-HBs seroconversion include active immunization (hepatitis B vaccine) and passive immunization (hepatitis B immunoglobulin, HBIG). Existing literature and preliminary findings from our team suggest that hepatitis B vaccine alone is ineffective in preventing relapse after clinical cure. This project proposes a multicenter, prospective, randomized controlled study. It will enroll CHB patients who have achieved HBsAg seroclearance with PegIFNα-based therapy, with the primary endpoint being the sustained HBsAg seroclearance rate at 48 weeks. The study will compare the efficacy between a group receiving HBIG immunization and a non-immunization control group. We anticipate that passive immunization with HBIG following HBsAg seroclearance will lead to a sustained clinical cure in CHB patients. This study aims to explore novel approaches for reducing relapse after clinical cure and pursuing complete cure, identify relevant biomarkers, and establish corresponding predictive models.
- Conditions
- Chronic Hepaititis B
- Being tested
- Hepatitis B Immunoglobulin (HBIg)
- Keywords
- hepatitis B immunoglobulin, functional cure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B Immunoglobulin (HBIg)Drug
Patients with HBsAg seroclearance will receive an intramuscular injection of HBIG 400 IU upon enrollment. Based on the results of the hepatitis B serology panel follow-up, a supplemental HBIG injection will be administered promptly when necessary (i.e., when anti-HBs is negative or anti-HBs < 100 mIU/mL), with the goal of achieving anti-HBs seroconversion and maintaining its level above 100 mIU/mL.
| Study group | Role | What they receive |
|---|---|---|
| HBIG immunization group | Experimental | Patients with HBsAg seroclearance will receive an intramuscular injection of HBIG 400 IU upon enrollment. Based on the results of the hepatitis B serology panel follow-up, a supplemental HBIG injection will be administered promptly when necessary (i.e., when anti-HBs is negative or anti-HBs < 100 mIU/mL), with the goal of achieving anti-HBs seroconversion and maintaining its level above 100 mIU/mL. Receives: Drug: Hepatitis B Immunoglobulin (HBIg) |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sustained HBsAg seroclearance rate (HBsAg < 0.05 IU/mL) at 48 weeks after initial HBsAg seroclearance
Measured: From enrollment to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepaititis BStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Feng, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328711
- Sponsor's protocol ID
- 202424084
- Status last verified
- May 2025
- First submitted
- 27 Dec 2025
- Last updated
- 9 Jan 2026
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Novel Immunomodulatory Therapeutic Regimens for Clinical Cure of Chronic Hepatitis B and Efficacy Prediction
- ClinicalTrials.gov ID
- NCT07328711
- Acronym / sponsor ID
- 202424084
- Conditions
- Chronic Hepaititis B
- Keywords
- hepatitis B immunoglobulin, functional cure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jan 2026 (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.
Achieving clinical cure, defined as hepatitis B surface antigen (HBsAg) seroclearance, represents a major research focus and an ideal therapeutic goal for chronic hepatitis B (CHB). A significant challenge in CHB management lies in promoting clinical cure, reducing relapse, and progressing towards complete cure. Studies have found that in patients who achieve HBsAg seroclearance following peginterferon alfa (PegIFNα) therapy, the seroconversion of anti-HBs and its attainment to a certain level are crucial for minimizing relapse. Strategies to promote anti-HBs seroconversion include active immunization (hepatitis B vaccine) and passive immunization (hepatitis B immunoglobulin, HBIG). Existing literature and preliminary findings from our team suggest that hepatitis B vaccine alone is ineffective in preventing relapse after clinical cure. This project proposes a multicenter, prospective, randomized controlled study. It will enroll CHB patients who have achieved HBsAg seroclearance with PegIFNα-based therapy, with the primary endpoint being the sustained HBsAg seroclearance rate at 48 weeks. The study will compare the efficacy between a group receiving HBIG immunization and a non-immunization control group. We anticipate that passive immunization with HBIG following HBsAg seroclearance will lead to a sustained clinical cure in CHB patients. This study aims to explore novel approaches for reducing relapse after clinical cure and pursuing complete cure, identify relevant biomarkers, and establish corresponding predictive models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBIG immunization group | Experimental | Drug: Hepatitis B Immunoglobulin (HBIg)Patients with HBsAg seroclearance will receive an intramuscular injection of HBIG 400 IU upon enrollment. Based on the results of the hepatitis B serology panel follow-up, a supplemental HBIG injection will be administered promptly when necessary (i.e., when anti-HBs is negative or anti-HBs < 100 mIU/mL), with the goal of achieving anti-HBs seroconversion and maintaining its level above 100 mIU/mL. |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 60 years (inclusive).
- Documented HBsAg and/or HBV DNA positivity for over 6 months.
- Achieved HBsAg seroclearance (<0.05 IU/mL) following a PegIFNα-based treatment regimen.
- HBeAg negative and HBV DNA <10 IU/mL.
- Good compliance and willingness to voluntarily sign the informed consent form.
Key exclusion criteria (8 listed)
- Current decompensated cirrhosis or a history of decompensated cirrhosis.
- Individuals with spontaneous or Nucleos(t)ide analogue-induced HBsAg seroclearance.
- Coinfection with other viruses, such as hepatitis A, C, D, E viruses, or human immunodeficiency virus (HIV).
- Severe concurrent physical or mental illnesses other than hepatitis B, including uncontrolled primary renal, cardiac, pulmonary, vascular, neurological, digestive, or severe metabolic diseases (e.g., uncontrolled hyperthyroidism, severe diabetic complications, adrenal disorders), immunodeficiency diseases, or severe infections; active or suspected malignancy, or a history of malignancy.
- Use of corticosteroids, immunosuppressants, or chemotherapeutic agents within the 6 months prior to enrollment or at present.
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 |
|---|---|---|
| Hepatitis B Immunoglobulin (HBIg)Patients with HBsAg seroclearance will receive an intramuscular injection of HBIG 400 IU upon enrollment. Based on the results of the hepatitis B serology panel follow-up, a supplemental HBIG injection will be administered promptly when necessary (i.e., when anti-HBs is negative or anti-HBs < 100 mIU/mL), with the goal of achieving anti-HBs seroconversion and maintaining its level above 100 mIU/mL. | Drug | HBIG immunization group |
Primary outcome
The sustained HBsAg seroclearance rate (HBsAg < 0.05 IU/mL) at 48 weeks after initial HBsAg seroclearance
Time frame: From enrollment to 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 9 Jan 2026.
- 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?
A Early Phase 1 study testing Hepatitis B Immunoglobulin (HBIg) in people with Chronic Hepaititis B, run by Peking University People's 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 5 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bo Feng (8613810254109, fengbo@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sustained HBsAg seroclearance rate (HBsAg < 0.05 IU/mL) at 48 weeks after initial HBsAg seroclearance (time frame: From enrollment to 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 9 Jan 2026.