Plasma Purification and Chronic Hepatitis B

Not Applicable

• Conditions: Chronic Hepatitis b
• Interventions: Device: HA+purification; Drug: active comarator using antiviral drug of nucleoside analogues

• Registration Number: NCT04518553
• Lead Sponsor: Shanghai Pudong Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-19
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17
• Study Start: 2021-03-23
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active interference	HA+purification	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.
active control	active comarator using antiviral drug of nucleoside analogues	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.

Primary Outcome Measures

Name	Time	Method
Concentration of HBV(hepatitis B virus) HBeAg is serologically negative	2 years	serological examination every three months

Secondary Outcome Measures

Name	Time	Method
Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly	2 years	serological examination every three months
Concentration of HBV-DNA virus load is undetected	2 years	serological examination by compared of HAs with HAs+plasma purification treatment
hepatitis B virus HBsAg serological transformation is negative	2 years	serological examination every three months