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临床试验/NCT04035837
NCT04035837进行中(未招募)4 期

A Study of Peg-interferon Treatment for Nucleos(t)Ide Analogues Suppressed Chronic Hepatitis B Patients With Low Level Hepatitis Surface Antigen

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2018年5月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
30,000
试验地点
1
主要终点
hepatitis B surface antigen

研究概览

简要总结

Chronic hepatitis B is a global public health problem, with nearly 700,000 deaths each year because of hepatitis B-related diseases. Recent studies have found that some patients who have used nucleot(s)ide analogues(NAs) for some period can achieve higher hepatitis B surface antigen(HBsAg) clearance rate(which is called clinical cure or functional cure) by using pegylated interferon. Patients who achieve clinical cure will further reduce liver inflammation, fibrosis and risks of liver cirrhosis and cancer in the future. This study was initiated in May 2018 and plans to recruit 30,000 eligible patients. The enrollment conditions are as follows: 1. according with the diagnosis of chronic hepatitis B in the guideline of China in 2015; 2.18-60 years old; 3. more than 1 year history of NAs therapy with HBsAg ≤1500 IU/ml, negative hepatitis e antigen and hepatitis B virus DNA<100 IU/ml; 4. no contraindications of interferon. For the above patients, pegylated interferon was used for 1-2 years(combined with NAs for at least 3 months).The primary goal of this study is to find out the optimal treatment for clinical cure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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

入选标准

  • according with the diagnosis of chronic hepatitis B in the guideline of China in 2015
  • 18-60 years old
  • more than 1 year history of nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA<100 IU/ml
  • no contraindications of interferon

排除标准

  • Allergy to interferon
  • Alanine transaminase >10 times of upper limit of normal(ULN) or total bilirubin >2 times of ULN
  • existing or previous decompensated liver cirrhosis
  • White blood cells or Platelet below the lower limit of normal
  • existing severe organ injury
  • combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism
  • confirmed or suspected malignant tumors
  • before or after transplantation
  • using immunosuppressor
  • pregnant or having a planned parenthood in 2 years
  • alcohol or drug addicted
  • infected by HIV
  • any conditions that is unsuitable to interferon therapy according to the doctors' judgement

研究组 & 干预措施

short-course combination group

Experimental

Nucleoside analogue is used during the first 3 months.

干预措施: pegylated interferon-alfa (Drug)

full-course combination group

Experimental

Nucleoside analogue is used during all the course of study.

干预措施: pegylated interferon-alfa (Drug)

Monotherapy group

Experimental

Only Peg-IFN is used during all the course of study.

干预措施: pegylated interferon-alfa (Drug)

结局指标

主要结局

hepatitis B surface antigen

时间窗: up to 48 weeks

hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.

次要结局

  • hepatitis B surface antibody(up to 48 weeks)

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

Zhiliang Gao

The director of the infectious diseases department

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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