HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 主要终点
- Number of patients with HBsAg loss
研究概览
简要总结
Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen "s" (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B (HBeAg-negative)
- •Signed inform consent
- •Aged > 18
排除标准
- •Contraindications for Pegylated interferon (cirrhosis, pregnancy, others)
- •Previous treatment with interferon or Pegylated interferon
- •Previous HBsAg loss
- •Treatment duration with Nucleos(t)ide analogues less than 2 years
- •Poor adherence to Nucleos(t)ide analogues
研究组 & 干预措施
Pegylated interferon alfa-2a
adding Pegylated interferon alfa-2a (180 microgs /week during 48 weeks) in HBeAg-negative patients receiving nucleos(t)ide analogues
干预措施: Pegylated interferon alfa-2a (Drug)
结局指标
主要结局
Number of patients with HBsAg loss
时间窗: 1 year after treatment completion
HBsAg will be evaluated one year after treatment completion (96 weeks). Efficacy will be calculated as a proportion (rate of patients with HBsAg loss/treated patients)
次要结局
未报告次要终点
研究者
José Antonio Carrion
Dr.
Parc de Salut Mar
