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. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.
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 single NAs for more than 12 months.
- •Hepatitis B e antigen (HBeAg)-negative.
- •Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.
- •Hepatitis B virus DNA <100 IU/mL.
排除标准
- •Patients with liver cirrhosis, Hepatocellular Carcinoma or AFP >2 ULN 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 with a previous use of IFN anti hepatitis B virus treatment or have NAs drug resistance.
- •Patients who can't come back to clinic for follow-up on schedule.
研究组 & 干预措施
Control
Patients do not need to change their NAs treatment.
干预措施: Nucleoside analogues (Drug)
Experimental
CHB patients with low level HBsAg.Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1000 IU/mL and Hepatitis B virus DNA <100 IU/mL, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.
干预措施: peginterferon alfa (Drug)
结局指标
主要结局
HBsAg Clearance
时间窗: 120 weeks
Percentage of Participants with HBsAg \<0.05 IU/mL.
HBsAg Seroconversion
时间窗: 120 weeks
Percentage of Participants with HBsAg \<0.05 IU/mL 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