A Phase 4 interventional study of Peg-IFN α-2b combined with NAs in Metabolic Dysfunction-Associated Steatotic Liver Disease and Chronic Hepatitis B, sponsored by Shenzhen Third People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Shenzhen Third People's Hospital · Phase 4, Interventional, and Treatment
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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 830 is above the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Shenzhen Third People's Hospital is the lead sponsor of 10 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Adults aged 18-65 years, regardless of gender; -positive for ≥6 months; HBeAg-negative; HBsAg quantification ≤1500 IU/mL; No restriction on HBV DNA quantification; \<10× (upper limit of normal, ≤400 IU/L); No prior interferon therapy within the past 1 year; Signed form obtained; Exclusion of comorbid metabolic dysfunction-associated steatotic liver disease (MASLD).
MASLD meets at least one of the following five metabolic criteria:
≥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 ≥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 . Patients co-infected with 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 count \<80×10\^9/L. Patients allergic to interferon, as well as those with to interferon indicated in the package insert.
Patients deemed unsuitable for enrollment by the researcher.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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;
Drug: Peg-IFN α-2b combined with NAs
Peg-IFN α-2b (1.5 μg/kg/week) combined with NAs
Primary study endpoint
The rate of HBsAg clearance in patients at 48 weeks of treatment.
Time frame: 48 weeks
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.
Time frame: 48 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Dec 2027, 28 months later.
Of 46 non-industry phase 4 interventional studies under Hepatitis B, Chronic, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 83. This study's planned 28 months is below that.
Counting every sponsor, half of 63 studies reached it within 43 months; a quarter within 30 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Shenzhen Third People's Hospital