Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 4NCT07071636
Clinical Efficacy of Pegylated Interferon Alpha-2b Combined With Nucleos(t)Ide Analogues in the Treatment of Chronic Hepatitis B Patients
A Phase 4 study testing Peg-IFN α-2b combined with NAs in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Chronic Hepatitis B, run by Shenzhen Third People's Hospital.
Trial summary
Background Chronic hepatitis B (CHB) is a global health issue that affects a large number of patients. There is currently controversy regarding the treatment strategies for CHB patients with metabolic-associated steatoliver disease (MASLD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Chronic Hepatitis B
- What is being tested?
- Peg-IFN α-2b combined with NAs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 30 Sep 2029
- Phase
- Phase 4
- 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
Inclusion Criteria: Adults aged 18-65 years, regardless of gender; HBsAg-positive for ≥6 months; HBeAg-negative; HBsAg quantification ≤1500 IU/mL; No restriction on HBV DNA quantification; ALT <10×ULN (upper limit of normal, ≤400 IU/L); No prior interferon therapy within the past 1 year; Signed informed consent form obtained; Exclusion of comorbid metabolic dysfunction-associated steatotic liver disease (MASLD).
MASLD meets at least one of the following five metabolic criteria:
BMI ≥23 or waist circumference >94 cm (male)/80 cm (female) Fasting plasma glucose ≥5.6 mmol/L or 2-hour postprandial blood glucose ≥7.8 mmol/L or HbA1c ≥5.7% or diagnosis of Type 2 Diabetes Mellitus or undergoing anti-diabetic therapy Blood pressure ≥130/85 mmHg or receiving antihypertensive medication Plasma triglycerides ≥1.70 mmol/L or current lipid-lowering treatment Plasma HDL-C: <1.0 mmol/L (male) or <1.3 mmol/L (female) or active lipid-modifying therapy -
Exclusion Criteria: Patients who are pregnant or breastfeeding. Excessive alcohol consumption: ethanol intake greater than 210g/week for males and greater than 120g/week for females (according to the "Guidelines for the Prevention and Treatment of Metabolic Associated (Non-alcoholic) Fatty Liver Disease (2024 Edition)") Individuals co-infected with HIV. Patients co-infected with HCV virus or other viral hepatitis and other chronic liver diseases.
Patients with liver cirrhosis (compensated or decompensated), liver failure, hepatocellular carcinoma, or any type of malignant tumor.
Patients with serious heart, brain, kidney, and hematopoietic system diseases or oncologic diseases.
Patients with severe psychiatric abnormalities as well as uncontrolled hypertension, diabetes, thyroid dysfunction, etc.
Peripheral blood leukocyte count <3.5×10^9/L and/or platelet count <80×10^9/L. Patients allergic to interferon, as well as those with contraindications to interferon indicated in the package insert.
Patients deemed unsuitable for enrollment by the researcher.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study Evaluating Pegylated Interferon Alpha-2b and Nucleos(t)Ide Analogues in Treating Chronic Hepatitis B With or Without Metabolic Dysfunction-Associated Steatotic Liver Disease
Background Chronic hepatitis B (CHB) is a global health issue that affects a large number of patients. There is currently controversy regarding the treatment strategies for CHB patients with metabolic-associated steatoliver disease (MASLD). Therefore, this study aims to conduct a prospective cohort study to compare the therapeutic effects of pegylated interferon α-2b (Peg IFNα-2b) combined with nucleos(t)ide analogues (NAs) in CHB patients with and without MASLD, and to explore the metabolic improvement effects of Peg IFNα-2b treatment in CHB patients with MASLD.
Design This study is a single-center, non-randomized controlled clinical trial. The subjects are CHB patients planned to receive Peg IFNα-2b combined with NAs, who will be naturally divided into two groups based on the presence or absence of MASLD. The study period is from September 15, 2024, to December 31, 2029, with a planned enrollment of 830 patients.
Read more
Methods Inclusion Criteria: Adults aged 18 to 65 years, with HBsAg positivity for more than 6 months, HBeAg negativity, HBsAg level ≤1500 IU/ml, ALT <10 ULN (400 IU/L), no interferon treatment in the past year, and signed informed consent.
Grouping Criteria: Patients will be divided into two groups based on the presence or absence of MASLD. MASLD is defined by hepatic steatosis confirmed by imaging or liver biopsy, and the presence of at least one of the following five metabolic factors: BMI ≥23 or waist circumference exceeding the standard, abnormal blood glucose, blood pressure ≥130/85 mmHg, plasma triglycerides ≥1.70 mmol/L, and abnormal plasma high-density lipoprotein cholesterol.
Exclusion Criteria: Pregnant or breastfeeding patients, heavy drinkers, patients with HIV infection, co-infected with other viral hepatitis, patients with liver cirrhosis or hepatocellular carcinoma, severe cardiocerebrovascular or renal diseases, psychiatric abnormalities, abnormal peripheral blood leukocytes or platelet count, interferon allergy, etc.
Withdrawal Criteria: Patients who withdraw informed consent, request to exit, experience severe adverse events, have serious protocol violations, become pregnant, have poor compliance, are lost to follow-up, or whose continued participation in the study is deemed unsafe by the investigator.
Research Endpoints Primary Endpoint: HBsAg clearance rate at 48 weeks of treatment. Secondary Endpoints: Proportion and baseline reduction of HBsAg <1500 IU/ml at the end of treatment, reduction of HBV DNA levels from baseline and proportion below the detection limit, clearance and seroconversion rates of HBeAg in HBeAg-positive patients, and the incidence of cardiovascular disease in MASLD patients at the end of treatment.
Conclusion This study aims to provide evidence for the individualized treatment of CHB patients with MASLD, clarify the impact of MASLD on the treatment response of CHB patients, optimize treatment protocols, increase clinical cure rates, and explore new strategies for improving patients' metabolic functions. Through this study, we hope to provide more precise decision-making support for clinicians, thereby improving patients' quality of life and long-term prognosis.
- Being tested
- Peg-IFN α-2b combined with NAs
- 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-IFN α-2b combined with NAsDrug
Peg-IFN α-2b (1.5 μg/kg/week) combined with NAs
| Study group | Role | What they receive |
|---|---|---|
| Peg-IFN α-2b combined with NAs | Experimental | received Peg-IFN α-2b combined with NAs Adults aged 18-65 years, regardless of gender; HBsAg-positive for ≥6 months; HBeAg-negative; HBsAg quantification ≤1500 IU/mL; No restriction on HBV DNA quantification; ALT <10×ULN (upper limit of normal, ≤400 IU/L); No prior interferon therapy within the past 1 year; Signed informed consent form obtained; Receives: Drug: Peg-IFN α-2b combined with NAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary study endpoint
The rate of HBsAg clearance in patients at 48 weeks of treatment.
Measured: 48 weeks
Secondary outcomes (1)
Secondary study endpoints
The proportion of patients with HBsAg <1500 IU/mL and the degree of reduction from baseline at the end of treatment; The degree of reduction in HBV DNA levels from baseline at the end of treatment and the proportion below the detection limit; The proportion of HBeAg-positive patients achieving HBeAg clearance and seroconversion at the end of treatment; The proportion of MASLD patients who develop cardiovascular diseases at the end of treatment.
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 posted17 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071636
- Sponsor's protocol ID
- 2024-242-02
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating Pegylated Interferon Alpha-2b and Nucleos(t)Ide Analogues in Treating Chronic Hepatitis B With or Without Metabolic Dysfunction-Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07071636
- Acronym / sponsor ID
- 2024-242-02
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 830 participants (estimated)
- Lead sponsor
- Shenzhen Third People's HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 17 Jul 2025 (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.
Background Chronic hepatitis B (CHB) is a global health issue that affects a large number of patients. There is currently controversy regarding the treatment strategies for CHB patients with metabolic-associated steatoliver disease (MASLD). Therefore, this study aims to conduct a prospective cohort study to compare the therapeutic effects of pegylated interferon α-2b (Peg IFNα-2b) combined with nucleos(t)ide analogues (NAs) in CHB patients with and without MASLD, and to explore the metabolic improvement effects of Peg IFNα-2b treatment in CHB patients with MASLD.
Design This study is a single-center, non-randomized controlled clinical trial. The subjects are CHB patients planned to receive Peg IFNα-2b combined with NAs, who will be naturally divided into two groups based on the presence or absence of MASLD. The study period is from September 15, 2024, to December 31, 2029, with a planned enrollment of 830 patients.
Methods Inclusion Criteria: Adults aged 18 to 65 years, with HBsAg positivity for more than 6 months, HBeAg negativity, HBsAg level ≤1500 IU/ml, ALT <10 ULN (400 IU/L), no interferon treatment in the past year, and signed informed consent.
Grouping Criteria: Patients will be divided into two groups based on the presence or absence of MASLD. MASLD is defined by hepatic steatosis confirmed by imaging or liver biopsy, and the presence of at least one of the following five metabolic factors: BMI ≥23 or waist circumference exceeding the standard, abnormal blood glucose, blood pressure ≥130/85 mmHg, plasma triglycerides ≥1.70 mmol/L, and abnormal plasma high-density lipoprotein cholesterol.
Exclusion Criteria: Pregnant or breastfeeding patients, heavy drinkers, patients with HIV infection, co-infected with other viral hepatitis, patients with liver cirrhosis or hepatocellular carcinoma, severe cardiocerebrovascular or renal diseases, psychiatric abnormalities, abnormal peripheral blood leukocytes or platelet count, interferon allergy, etc.
Withdrawal Criteria: Patients who withdraw informed consent, request to exit, experience severe adverse events, have serious protocol violations, become pregnant, have poor compliance, are lost to follow-up, or whose continued participation in the study is deemed unsafe by the investigator.
Research Endpoints Primary Endpoint: HBsAg clearance rate at 48 weeks of treatment. Secondary Endpoints: Proportion and baseline reduction of HBsAg <1500 IU/ml at the end of treatment, reduction of HBV DNA levels from baseline and proportion below the detection limit, clearance and seroconversion rates of HBeAg in HBeAg-positive patients, and the incidence of cardiovascular disease in MASLD patients at the end of treatment.
Conclusion This study aims to provide evidence for the individualized treatment of CHB patients with MASLD, clarify the impact of MASLD on the treatment response of CHB patients, optimize treatment protocols, increase clinical cure rates, and explore new strategies for improving patients' metabolic functions. Through this study, we hope to provide more precise decision-making support for clinicians, thereby improving patients' quality of life and long-term prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peg-IFN α-2b combined with NAs | Experimental | Drug: Peg-IFN α-2b combined with NAsreceived Peg-IFN α-2b combined with NAs Adults aged 18-65 years, regardless of gender; HBsAg-positive for ≥6 months; HBeAg-negative; HBsAg quantification ≤1500 IU/mL; No restriction on HBV DNA quantification; ALT <10×ULN (upper limit of normal, ≤400 IU/L); No prior interferon therapy within the past 1 year; Signed informed consent form obtained; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-IFN α-2b combined with NAsPeg-IFN α-2b (1.5 μg/kg/week) combined with NAs | Drug | Peg-IFN α-2b combined with NAs |
Primary outcome
Primary study endpoint
Time frame: 48 weeks
The rate of HBsAg clearance in patients at 48 weeks of treatment.
1 secondary outcome
Secondary study endpoints
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 17 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peg-IFN α-2b combined with NAs in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Chronic Hepatitis B, run by Shenzhen Third People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Qingxian Cai, professor (18127814825, 41180423@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary study endpoint (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 17 Jul 2025.