跳至主要内容
临床试验/NCT04518553
NCT04518553Unknown不适用

Shanghai Pudong Hospital

Shanghai Pudong Hospital0 个研究点目标入组 230 人开始时间: 2021年3月23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
发起方
入组人数
230
主要终点
Concentration of HBV(hepatitis B virus) HBeAg is serologically negative

研究概览

简要总结

To compare the efficacy of nucleoside analogues (HA) alone and plasma purification +HA in reducing HBV viral load.

详细描述

Chronic hepatitis B (CHB) is a major disease harmful to human health and an important cause of liver cirrhosis and liver cancer. Hepatitis B virus (HBV) cccDNA exists for a long time in the liver of infected persons and serves as a template for HBV replication, which makes it difficult to eradicate HEPATITIS B virus infection. Antiviral drugs are commonly used clinically, including interferon and nucleoside analogues, but there are problems of recurrence and drug resistance. These drugs are not directly targeted at cccDNA and are therefore inefficient at reducing cccDNA. How to quickly and efficiently reduce the viral load of HBV-DNA, inhibit THE TRANSCRIPTION of HBV-CCCDNA RNA, and promote the negative conversion of HBeAg is an urgent problem to be solved at present, so it is particularly important to find other more effective drugs or methods. Plasma purification is a new treatment method in which the pathogenic factors (hepatitis B virus, etc.) are trapped in the hollow fibers by special membrane materials and removed. Therefore, this study adopts the randomized control method to explore the effect of plasma purification on HBV clearance, aiming to explore the effectiveness and safety of plasma purification in reducing HBV DNA viral load and inhibiting HBV cccDNA RNA transcription, so as to provide new treatment ideas and methods for future treatment of hepatitis B virus infection, which is beneficial to the society and individuals.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Chronic hepatitis B Disease
  • hepatitis B virus HBeAg is positive
  • hepatitis B virus HBV-DNA virus load is more than 100000cps/ml

排除标准

  • Hypotension
  • Cardiopulmonary insufficiency
  • Coagulation disorders
  • Heparin allergy

研究组 & 干预措施

active control

Active Comparator

antiviraltherapy using HA using antiviralHA drugs of HA to decrease HBV-DNA load. In this group, patients with chronic hepatitis B just take antiviral drug of HAs to control hepatitis B viral without active interference.

干预措施: active comarator using antiviral drug of nucleoside analogues (Drug)

active interference

Experimental

HA+plasma purification as active interference. HA antiviral therapy using HA plus plasma purification every three months.DFT as plasma purification mode will be used. DFT therapy time lasts 2.5-3 hours each time.After three months, DFT therapy will be used if patients' HBV-DNA loads are higher than cut-off normal level.

干预措施: HA+purification (Device)

结局指标

主要结局

Concentration of HBV(hepatitis B virus) HBeAg is serologically negative

时间窗: 2 years

serological examination every three months

次要结局

  • Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly(2 years)
  • Concentration of HBV-DNA virus load is undetected(2 years)
  • hepatitis B virus HBsAg serological transformation is negative(2 years)

研究者

发起方
Shanghai Pudong Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin HM, MD

professor

Shanghai Pudong Hospital

相似试验