HBsAg Loss/Seroconversion in Inactive Chronic Hepatitis B Carriers Treated With Peginterferon Alpha-2a
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- HBsAg loss/seroconversion
研究概览
简要总结
Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive carriers.
The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would not generally be considered candidates for therapy.
详细描述
Chronic HBV inactive carriers were enrolled in the out-patient department of Beijing Ditan Hospital. All of them were HBsAg positive and anti-HBs negative for more than 6 months with persistent undetectable HBV DNA and normal ALT levels measured at 3-6 monthly intervals during the preceding 2 years as well as with serum HBsAg levels ≤100 IU/mL determined on two occasions during the month prior to treatment. All patients did not have other liver diseases and contraindications for interferon therapy.
After giving informed consent, patients were treated with weekly subcutaneous injections of peginterferon alpha-2a 180 µg. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.
In this study, the only parameter to assessing the treatment response was HBsAg level change. Treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 mIU/mL) defined as seroconversion.
Depending on the decline of HBsAg level, treatment was either continued for a prolonged period until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels on three months treatment.
Liver function parameters, including ALT, aspartate aminotransferase (AST), albumin (ALB) and total bilirubin (Tbil) were examined using an automated biochemical analyzer. Peripheral blood neutrophil and platelet count were detected before treatment, and monitored during treatment with one to three month intervals, and base on the test results to adjust the next checking time. Quantitative HBV DNA testing was conducted using a commercially available real-time fluorescence quantitative PCR kit. HBsAg levels were quantified with Architect i2000 HBsAg quantitative assay (Abbott Laboratories) kit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg positive and anti-HBs negative for more than 6 months
- •HBeAg-negative/anti-HBe-positive
- •Persistently undetectable HBV DNA with normal ALT levels, as established at 3-6 monthly intervals during the preceding 2 yrs
- •Serum HBsAg levels ≤100 IU/mL, as determined on two occasions during the month prior to treatment
- •Absence of previous antiviral therapy
排除标准
- •With active alcohol and/or drugs consumption
- •With human immunodeficiency virus or hepatitis C virus coinfections
- •With clinical evidence of cirrhosis
- •With history of autoimmune hepatitis
- •With hematological or psychiatric diseases
- •With evidence of neoplastic diseases
- •With severe cardiac or pulmonary disease
研究组 & 干预措施
peginterferon alpha 2a
the inactive chronic HBsAg carriers were treated with peginterferon alpha 2a for 72 weeks and followed for 24 weeks.
干预措施: Pegylated interferon alfa-2a (Drug)
结局指标
主要结局
HBsAg loss/seroconversion
时间窗: HBsAg level was lower than 0.05IU/mL after 96 weeks treatment
HBsAg loss was defined as HBsAg levels \<0.05 IU/mL. Anti-HBs was measured using Architect i2000 kit,and anti-HBs \>10 mIU/L was considered positive.
次要结局
未报告次要终点
研究者
Yao Xie
Director of division 4, liver diseases center
Beijing Ditan Hospital
