The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HBsAg Clearance
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 and NAs.
详细描述
In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.
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
- •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(Roche Cobas).
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
PEG-IFN group
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-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.
干预措施: Peginterferon alfa (Drug)
结局指标
主要结局
HBsAg Clearance
时间窗: 72 weeks
Percentage of Participants with HBsAg negative.
HBsAg Seroconversion
时间窗: 72 weeks
Percentage of Participants with HBsAg negative and anti-HBsAg positive.
次要结局
未报告次要终点
研究者
Zhiliang Gao
chief director of department of infectious disease
Third Affiliated Hospital, Sun Yat-Sen University