A Study on the Pursuit of Sustained Clearance of HBsAg in Chronic Hepatitis B(CHB) Patients With Previous Interferon Treatment Using Pegylated Interferon Alpha

NCT07537387 | Not Yet Recruiting

• 1 other identifier: Leading Study2.0
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

CHB; Peginterferon; retreatment

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects with undetectable HBsAg

  Week 48

• Percentage of subjects with undetectable HBV DNA

  Week 48

Secondary Outcomes (8)

• Number of patients with a decrease in HBV DNA from baseline

  Week 1-48

• Proportion of subjects with HBV DNA below the lower limit of detection

  Week 1-48

• Number of patients with a decrease in HBsAg from baseline

  Week 1-48

• Proportion of HBsAg seroclearance

  Week 1-48

• Proportion of HBsAg seroconversion

  Week 1-48

Study Arms (2)

Peginterferon α-2b based treatment group

Drug: PEG IFNα-2b monotherapy or combination therapy with NAs

NAs monotherapy group

Drug: NAs monotherapy group

Interventions

PEG IFNα-2b monotherapy or combination therapy with NAs DRUG

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.

Peginterferon α-2b based treatment group

NAs monotherapy group DRUG

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 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic hepatitis B patients who received pegylated interferon alpha for the first time and achieved a good response.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• xieqing: lead

Study Sites (1)

Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Combined Modality Therapy; nas

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Qing Xie

  Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Xie

CONTACT

13651804273; xieqingrjh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ruijin Hospital

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 17, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)