A Prospective, Multicenter, Non-randomized, Controlled Study to Pursuit Clinical Functional Cure of Pegylated Interferon α in Previously Interferon-treated Chronic Hepatitis B （Leading Study）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,016
- 试验地点
- 1
- 主要终点
- Proportion of patients with HBsAg below the lower limit of detection.
研究概览
简要总结
Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy.
This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Understand and sign the informed consent, participate in the study voluntarily.
- •Aged between 18 and 65 (including 18 and 65).
- •HBsAg positive for at least 6 months or other evidence suggests chronic hepatitis B.
- •Had previously received interferon therapy, and discontinuation for at least 6 months at the time of enrollment, with a HBsAg level declined for at least 80% at the end of interferon treatment compared to the level of treatment started.
- •HBsAg≤500 IU/mL at screening, and HBsAg rebound should not exceed 50% when compared to the HBsAg level of previously interferon treatment started.
- •The pregnancy test within 24 hours previous to the first medication must be negative for women of childbearing. And all participants (male and female) should use effective contraception during the study period.
排除标准
- •Pregnant or lactating women, or those who had a birth plan during the study period.
- •Patients with neuropsychiatric disorders, especially depression, anxiety, mania, schizophrenia and other mental illness history or family history of mental illness.
- •Patients with chronic liver disease caused by hepatitis A, hepatitis C, hepatitis E and/or HIV infection, or other causes (such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease, etc.).
- •Evidence of acute severe liver damage: ALT>10 ULN, or markedly elevated ALT with significantly elevated bilirubin.
- •Evidence of uncompensated liver disease: ascites, esophageal and gastric varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc. Or previous evidence of decompensation of cirrhosis.
- •Patients with evidence of hepatocellular carcinoma or AFP>1 ULN.
- •Kidney diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc. Or serum creatinine >1 ULN at screening.
- •Neutrophil count <1.5×10^9/L, platelet count <90×10^9/L, blood phosphorus < 0.8 mmol /L.
- •Autoimmune diseases (such as psoriasis, systemic erythematosus, etc.), endocrine system diseases (such as thyroid diseases, diabetes, etc.), hypertension (blood pressure ≥140/90 mmHg) poorly controlled by prescription drugs, serious history of heart disease (especially in the past 6 months), severe retinopathy or other serious eye diseases. Patients with organic disease or dysfunction of other vital organs.
- •Patients who plan to receive organ transplant or have already undergone organ transplant.
- •Patients who allergic to the investigational drug or any of its excipients, or who meet any contraindication declared in the instructions of the investigational drug.
- •Other conditions that are considered inappropriate for enrollment by the investigator.
研究组 & 干预措施
Peginterferon α-2b based treatment group
干预措施: Peginterferon α-2b based treatment group (Drug)
NAs monotherapy group
干预措施: NAs monotherapy group (Drug)
结局指标
主要结局
Proportion of patients with HBsAg below the lower limit of detection.
时间窗: Week 48
次要结局
- Decrease of HBV DNA levels at week 48 compared to baseline.(Week 48)
- Proportion of patients with HBV DNA below the lower limit of detection.(Week 48)
- Proportion of patients with HBsAg seroconversion.(Week 48)
- Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive.(Week 48)
- Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive.(Week 48)
- Decrease of HBsAg levels at week 48 compared to baseline.(Week 48)
- Serious adverse events.(from baseline to 48 weeks.)
研究者
Qing XIe
Director of Department of Infectious Disease, Rui Jin
Ruijin Hospital