Sustained Viral Response and HBsAg Level Changes in Chronic Hepatitis B Patients Who Achieved HBsAg Level≤100 IU/ml After Completed Interferon Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the rate of sustained viral response
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 -negative patients, and the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring good long term outcomes in patients with chronic hepatitis B. it was not clear whether patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained viral response and the state of HBsAg level≤100 IU/ml.
详细描述
The patients with chronic hepatitis B and achieved HBsAg level≤100 IU/ml after completed 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, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is HBV DNA reaction. The secondary endpoints is HBsAg loss.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level 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 viral response
时间窗: 96 weeks
The serum HBV DNA will be tested every 3 month for 96 weeks after completed treatment in chronic hepatitis B patients who achieved serum HBsAg level≤100 IU/ml with HBV DNA undetectable by interferon therapy. The rate of sustained viral response defined HBV DNA level maintaining undetectable during observation period will be evaluated, and HBV reaction is defined as serum HBV DNA reverse back to detectable level.
次要结局
- the rate of HBsAg loss(96 weeks)
研究者
Yao Xie
liver diseases center
Beijing Ditan Hospital