Chronic Hepatitis bNCT07537387
A Study on the Pursuit of Sustained Clearance of HBsAg in Chronic Hepatitis B(CHB) Patients With Previous Interferon Treatment Using Pegylated Interferon Alpha
An observational study of Chronic Hepatitis b, run by xieqing at 1 site in China.
Trial summary
This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- PEG IFNα-2b monotherapy or combination therapy with NAs and NAs monotherapy group
- Type of treatment
- Injection or infusion
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 31 Dec 2030
- 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
- Adult, Older adult
Study population: Chronic hepatitis B patients who received pegylated interferon alpha for the first time and achieved a good response.
Who may be able to join
- • Voluntary participation and ability to understand and provide written informed consent.
- Age 18-65 years (inclusive), either gender.
- Documented HBsAg positivity for at least 6 months, or other evidence confirming chronic hepatitis B (CHB).
- Prior interferon therapy before enrollment (treatment discontinuation ≥ 3 months), with HBsAg level at the end of prior treatment reduced by ≥ 50% from baseline.
- HBsAg ≤ 500 IU/mL at screening, and HBsAg rebound at screening not exceeding 50% of the baseline HBsAg level during the first-round interferon therapy.
- Negative pregnancy test within 24 hours prior to the first dose (for women of childbearing potential); all subjects (male and female) must use effective contraceptive measures during the study.
Who cannot join
- • Pregnant or lactating women, or subjects with a pregnancy plan during the study period.
- Subjects with neuropsychiatric disorders, in particular a history of depression, anxiety, mania, schizophrenia, or a family history of psychiatric disorders (especially a history of depression or depressive tendency).
- Concurrent active infection with hepatitis A, hepatitis C, hepatitis E and/or HIV, or chronic liver disease due to other causes (e.g., alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, etc.).
- Evidence of acute severe liver damage: e.g., ALT > 10 × ULN, or marked ALT elevation accompanied by significant hyperbilirubinemia.
- Evidence of decompensated liver disease: e.g., ascites, esophagogastric variceal bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or prior evidence of decompensated cirrhosis.
- Evidence of hepatocellular carcinoma (HCC), or AFP > 1 × ULN.
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- Renal diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or serum creatinine > 1 × ULN at screening.
- Neutrophil count < 1.5 × 10⁹/L, platelet count < 90 × 10⁹/L, or serum phosphorus < 0.8 mmol/L during the screening period.
- Autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus, etc.), endocrine disorders (e.g., thyroid diseases, diabetes, etc.), hypertension poorly controlled by prescription medications (blood pressure ≥ 140/90 mmHg), a history of severe heart disease (especially poorly controlled within 6 months), severe retinopathy or other serious ophthalmologic diseases, or other organic lesions or dysfunction of vital organs.
- Subjects planning to undergo or having previously undergone organ transplantation.
- Subjects with hypersensitivity to the investigational product or its excipients, or meeting any contraindication listed in the prescribing information of the investigational product.
- Other conditions deemed inappropriate for enrollment by the investigator
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
Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Qing Xie, 13651804273, xieqingrjh@163.com
About this study
Official title: A Prospective, Non-Randomized, Multicenter Study of Peginterferon Alfa for Pursuing Sustained Hepatitis B Surface Antigen(HBsAg) Clearance in Interferon-Pretreated Patients With Chronic Hepatitis B
This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in interferon-experienced patients with chronic hepatitis B (CHB). Subjects will receive either interferon-based therapy or NAs monotherapy based on their personal willingness and physicians' professional recommendations, with a uniform 48-week treatment course for all enrolled patients.
- Conditions
- Chronic Hepatitis b
- Being tested
- PEG IFNα-2b monotherapy or combination therapy with NAs, NAs monotherapy group
- Keywords
- CHB, Peginterferon, retreatment
- 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.
PEG IFNα-2b monotherapy or combination therapy with NAsDrug
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
NAs monotherapy groupDrug
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon α-2b based treatment group | Not described Receives: Drug: PEG IFNα-2b monotherapy or combination therapy with NAs | |
| NAs monotherapy group | Not described Receives: Drug: NAs monotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with undetectable HBsAg
Measured: Week 48
Percentage of subjects with undetectable HBV DNA
Measured: Week 48
Secondary outcomes (8)
Number of patients with a decrease in HBV DNA from baseline
Measured: Week 1-48
Proportion of subjects with HBV DNA below the lower limit of detection
Measured: Week 1-48
Number of patients with a decrease in HBsAg from baseline
Measured: Week 1-48
Proportion of HBsAg seroclearance
Measured: Week 1-48
Proportion of HBsAg seroconversion
Measured: Week 1-48
Proportion of HBeAg seroclearance
Measured: Week 1-48
Proportion of HBeAg seroconversion
Measured: Week 1-48
Serious adverse events
Measured: Week 1-48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xieqing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xieqing, Ruijin Hospital
- Investigators
- Qing Xie, Principal investigator, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537387
- Sponsor's protocol ID
- Leading Study2.0
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Multicenter Study of Peginterferon Alfa for Pursuing Sustained Hepatitis B Surface Antigen(HBsAg) Clearance in Interferon-Pretreated Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07537387
- Acronym / sponsor ID
- Leading Study2.0
- Conditions
- Chronic Hepatitis b
- Keywords
- CHB, Peginterferon, retreatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- xieqingUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Apr 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.
This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in interferon-experienced patients with chronic hepatitis B (CHB). Subjects will receive either interferon-based therapy or NAs monotherapy based on their personal willingness and physicians' professional recommendations, with a uniform 48-week treatment course for all enrolled patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon α-2b based treatment group | – | Drug: PEG IFNα-2b monotherapy or combination therapy with NAs |
| NAs monotherapy group | – | Drug: NAs monotherapy group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis B patients who received pegylated interferon alpha for the first time and achieved a good response.
Key inclusion criteria (6 listed)
- • Voluntary participation and ability to understand and provide written informed consent.
Key exclusion criteria (12 listed)
- • Pregnant or lactating women, or subjects with a pregnancy plan during the study period.
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 |
|---|---|---|
| PEG IFNα-2b monotherapy or combination therapy with NAsPeginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered. | Drug | Peginterferon α-2b based treatment group |
| NAs monotherapy groupPeginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered. | Drug | NAs monotherapy group |
Primary outcome
Percentage of subjects with undetectable HBsAg
Time frame: Week 48
Percentage of subjects with undetectable HBV DNA
Time frame: Week 48
8 secondary outcomes
Number of patients with a decrease in HBV DNA from baseline
Time frame: Week 1-48
Proportion of subjects with HBV DNA below the lower limit of detection
Time frame: Week 1-48
Number of patients with a decrease in HBsAg from baseline
Time frame: Week 1-48
Proportion of HBsAg seroclearance
Time frame: Week 1-48
Proportion of HBsAg seroconversion
Time frame: Week 1-48
Proportion of HBeAg seroclearance
Time frame: Week 1-48
Proportion of HBeAg seroconversion
Time frame: Week 1-48
Serious adverse events
Time frame: Week 1-48
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 17 Apr 2026.
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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.
Qing Xie principal investigator
Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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 Chronic Hepatitis b, run by xieqing 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 17 Apr 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.
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 Qing Xie (13651804273, xieqingrjh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with undetectable HBsAg (time frame: Week 48). The study lists 2 primary outcomes in all. 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 17 Apr 2026.