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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат PEG IFNα-2b monotherapy or combination therapy with NAs
  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.
• Препарат NAs monotherapy group
  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.

Первичные конечные точки

• Percentage of subjects with undetectable HBsAg [Срок оценки: Week 48]
• Percentage of subjects with undetectable HBV DNA [Срок оценки: Week 48]

Вторичные конечные точки (8)

• Number of patients with a decrease in HBV DNA from baseline [Срок оценки: Week 1-48]
• Proportion of subjects with HBV DNA below the lower limit of detection [Срок оценки: Week 1-48]
• Number of patients with a decrease in HBsAg from baseline [Срок оценки: Week 1-48]
• Proportion of HBsAg seroclearance [Срок оценки: Week 1-48]
• Proportion of HBsAg seroconversion [Срок оценки: Week 1-48]
• Proportion of HBeAg seroclearance [Срок оценки: Week 1-48]
• Proportion of HBeAg seroconversion [Срок оценки: Week 1-48]
• Serious adverse events [Срок оценки: Week 1-48]

Критерии участия

Критерии включения

• • 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.

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07537387 · Leading Study2.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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