NCT07537387尚未招募不适用
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
xieqing1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2026年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Percentage of subjects with undetectable HBsAg
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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
研究组 & 干预措施
Peginterferon α-2b based treatment group
干预措施: PEG IFNα-2b monotherapy or combination therapy with NAs (Drug)
NAs monotherapy group
干预措施: NAs monotherapy group (Drug)
结局指标
主要结局
Percentage of subjects with undetectable HBsAg
时间窗: Week 48
Percentage of subjects with undetectable HBV DNA
时间窗: Week 48
次要结局
- Proportion of HBsAg seroconversion(Week 1-48)
- 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 HBeAg seroclearance(Week 1-48)
- Proportion of HBeAg seroconversion(Week 1-48)
- Serious adverse events(Week 1-48)
研究者
xieqing
Ruijin Hospital
Ruijin Hospital
研究点 (1)
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