The Optimizing Treatment of Peginterferon Alpha in HBeAg-negative Chronic Hepatitis B Virus 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
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/mL).
详细描述
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally. HBeAg-negative CHB patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled in the out-patient department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg positive and anti-HBs negative for more than 6 months with HBV DNA<100 IU/mL and HBsAg levels <1000 IU/mL. All patients did not have other liver diseases and contraindications for interferon therapy.
After giving informed consent, patients were treated with NAs once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.
In this study, treatment endpoint was HBsAg loss(<0.05 IU/mL).Anti-HBs positive(>10 milli-International unit)(mIU/mL) defined as seroconversion. Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in case of nonresponse.
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 and had a history of NAs drug resistance or suboptimal/partial virological response.
- •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 alpha feto protein (AFP) >2 upper limit of normal(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.
- •Patients who can't come back to clinic for follow-up on schedule.
研究组 & 干预措施
PEG-IFN group
HBeAg-negative CHB patients with HBsAg <1000 IU/ mL and HBV DNA<100 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.
干预措施: peginterferon alfa (Drug)
结局指标
主要结局
HBsAg Clearance
时间窗: 96 weeks
Percentage of Participants with HBsAg \<0.05 IU/mL.
次要结局
- HBsAg Seroconversion(96 weeks)
研究者
Zhiliang Gao
Chief director of department of infectious disease
Third Affiliated Hospital, Sun Yat-Sen University