NCT07071636

Clinical Efficacy of Pegylated Interferon Alpha-2b Combined With Nucleos(t)Ide Analogues in the Treatment of Chronic Hepatitis B Patients

Not yet recruiting Phase 4 Last updated 17 July 2025

What this trial tests

Phase 4 trial testing Peg-IFN α-2b combined with NAs in Metabolic Dysfunction-Associated Steatotic Liver Disease in 830 participants. Not yet recruiting.

Timeline

15 August 2025

Primary endpoint
31 December 2027

30 September 2029

Quick facts

Lead sponsor	Shenzhen Third People's Hospital
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	830
Start date	15 August 2025
Primary completion	31 December 2027
Estimated completion	30 September 2029

Drugs / interventions tested

• Peg-IFN α-2b combined with NAs — full drug profile →

Conditions studied

• Metabolic Dysfunction-Associated Steatotic Liver Disease — all drugs for Metabolic Dysfunction-Associated Steatotic Liver Disease →
• Chronic Hepatitis B — all drugs for Chronic Hepatitis B →

Sponsor

Shenzhen Third People's Hospital

Who can join

Adults 18 to 65, any sex, with Metabolic Dysfunction-Associated Steatotic Liver Disease or Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.