Shanghai Pudong Hospital
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
- 否
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
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
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
Jin HM, MD
professor
Shanghai Pudong Hospital
