Plasma Purification and Chronic Hepatitis B

Shanghai Pudong Hospital

Status: Unknown

Conditions: Chronic Hepatitis b

Treatments: Device: HA+purification; Drug: active comarator using antiviral drug of nucleoside analogues

Study type: Interventional

Funder types: Other

Identifiers

NCT04518553

ShanghaiPudongH4

Details and patient eligibility

About

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

Full description

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Hypotension
2. Cardiopulmonary insufficiency
3. Coagulation disorders
4. Heparin allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

active control

Active Comparator group

Description:

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.

Treatment:

Drug: active comarator using antiviral drug of nucleoside analogues

active interference

Experimental group

Description:

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.

Treatment:

Device: HA+purification