Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- The rate of sustained HBsAg negativity and viral response in 96 weeks
研究概览
简要总结
Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC).HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and HBeAg-negative patients, as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN treatment. The primary analysis will be performed at the end of 96 weeks. Following the completion of the study period of 96 weeks, patients will be offered to participate in a long term study for further observation of additional 144 weeks (total of 240 weeks from the enrollment).
详细描述
Chronic hepatitis B patients who have achieved HBsAg loss from interferon treatment will be enrolled and observed for 96 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period. Their liver function and chemistry tests are also performed every 3 months. The liver ultrasonic examination would be taken every 3-6 months. The primary measurement is the percentage of patients who have positive HBsAg and/or a detectable level of HBV DNA. Following the completion of the study period, patients will be offered to participate in a long term study for further observation of additional 144 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had chronic hepatitis B and achieved HBsAg loss by interferon treatment.
排除标准
- •Active consumption of alcohol and/or drugs
- •Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- •History of autoimmune hepatitis
- •Psychiatric disease
- •Evidence of neoplastic diseases of the liver
结局指标
主要结局
The rate of sustained HBsAg negativity and viral response in 96 weeks
时间窗: From the enrollment to 96 weeks
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 96 weeks after completing treatment with interferon
次要结局
- The rate of sustained HBsAg negativity and viral response in subset analysis for long term(From the enrollment to 240 weeks)
- The rate of sustained HBsAg negativity and viral response in subset analysis in 96 weeks(From the enrollment to 96 weeks)
- The rate of sustained HBsAg negativity and viral response in long term(From the enrollment to 240 weeks)
- Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in long term(From the enrollment to 240 weeks)
- Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in 96 weeks(From the enrollment to 96 weeks)
研究者
Yao Xie
Liver Diseases Center
Beijing Ditan Hospital