跳至主要内容
临床试验/NCT02743182
NCT02743182已完成不适用

HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.

José Antonio Carrion0 个研究点目标入组 119 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

发起方
José Antonio Carrion
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

José Antonio Carrion

Dr.

Parc de Salut Mar

相似试验