A Study on Optimizing HBsAg Clearance in CHB Patients With Sequential Treatment of Pegylated Interferon Alpha-2b and Nucleoside Analogues
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- HBsAg loss
研究概览
简要总结
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha-2b and NAs.
详细描述
CHB Patients who had received, and responded to, NAs for more than 12 months are switched to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •CHB patients who had received NAs for more than 12 months.
- •Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
- •Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
- •Hepatitis B virus DNA not detectable.
排除标准
- •Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
- •Patients with other factors causing liver diseases.
- •Pregnant and lactating women.
- •Patients with concomitant HIV infection or congenital immune deficiency diseases.
- •Patients with diabetes, autoimmune diseases.
- •Patients with important organ dysfunctions.
- •Patients with serious complications ( e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding. )
- •Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
- •Patients who can't come back to clinic for follow-up on schedule.
研究组 & 干预措施
CHB patients
Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks.
干预措施: Peginterferon alfa-2b (Drug)
结局指标
主要结局
HBsAg loss
时间窗: Week 48
次要结局
未报告次要终点
研究者
Xiang Zhu
Attending Physician
Third Affiliated Hospital, Sun Yat-Sen University