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临床试验/NCT05753280
NCT05753280已完成4 期

Effect of Serum Vitamin D Level and Vitamin D Receptor on the Efficacy of Pegylated Interferon in Patients With Chronic Hepatitis B With Low Level HBsAg Treated by Nucleos(t)Ide Analogues

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年12月1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
已完成
发起方
入组人数
90
试验地点
1
主要终点
hepatitis B surface antigen

研究概览

简要总结

In recent years, vitamin D (VD) has received much attention in the fields of host immune regulation, inflammation, fibrosis, cell proliferation and differentiation and tumor. VD works by binding to the vitamin D receptor (VDR). VDR is mainly distributed in giant cells, dendritic cells, T cells and lymphocytes. Four SNPs of VDRS have been most studied: TaqI (rs731236), FokI (rs10735810), ApaI (rs7975232), and BsmI (rs1544410). At present, more and more patients have been treated with oral nucleotide/nucleoside analogues (NAs) with direct antiviral drugs in China, and a large part of them show low expression of HBsAg. Clinical cure can be pursued for these patients, that is, HBsAg turns negative. A number of studies have been carried out at home and abroad.

In this study, We will recruit CHB patients with low HBsAg levels. They all will receive pegylated interferon treatment and were randomly assigned to a vitamin D treatment or a control group. A final assessment will be made to determine whether vitamin D levels would affect the clearance rate of HBsAg.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • 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 nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA<100 IU/ml 4.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

treatment group

Experimental

pegylated interferon 180ug/week and oral vitamin D3 800IU/day for no longer than 48 weeks

干预措施: Vitamin D (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(every 12 weeks for 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

Academic leader of the infectious diseases department

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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