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临床试验/NCT01892241
NCT01892241已完成3 期

Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA

Third Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 74 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
74
主要终点
Complete viralogic response

研究概览

简要总结

Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.

详细描述

It was a prospective, non-randomized, open-label study that evaluated the efficacy and safety of pegasys treatment in chronic hepatitis B patients with spontaneous HBVDNA decline after acute exacerbation.Patients with spontaneous decline of HBV DNA(a decrease of HBV DNA levels of more than 2 log(10) IU/mL as compared to baseline before antiviral treatment) after acute exacerbation (ALT was 10-30ULN,TBIL was 2-20mg/ml,PTA>60%)were non-randomly divided into 3 groups: group A, B and C. Before treatment, the patients were counselled on the advantages and disadvantages of taking peginterferon or nucleos(t)ide analogue, and the subsequential treatment were decided by themselves. Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks. Group B and C were control group, cases in group B received an continual entecavir therapy(0.5 mg orally once daily) and those in group C didn't accept any antiviral regiment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

180µg of peginterferon alfa-2a

Experimental

Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.

干预措施: Pegasys(Roche) (Drug)

Entecavir

Active Comparator

cases in group B received an continual entecavir therapy(0.5 mg orally once daily)

干预措施: Entecavir (Drug)

结局指标

主要结局

Complete viralogic response

时间窗: week 96

Complete viralogic response was defined as suppression of HBV DNA to the level below 60IU/mL(detected by Cobas Amplicor HBV Monitor Test, Roche Diagnostics).

次要结局

  • Sick leave in patients in different groups(week 48,72 and 96)
  • HBsAg loss and seroconversion(week 24,48,72 and 96)
  • ALT normalization(week 24,48,72 and 96)

研究者

发起方
Third Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cai Qingxian

Doctor

Third Affiliated Hospital, Sun Yat-Sen University

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