Plasma Purification and Chronic Hepatitis B

NCT ID: NCT04518553

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2023-09-30

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.

Conditions

Chronic Hepatitis b

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

active comarator using antiviral drug of nucleoside analogues

Intervention Type: DRUG

using antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus.

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.

Group Type: EXPERIMENTAL

HA+purification

Intervention Type: DEVICE

Based on antiviral drug of nucleoside analogues, plasma purification is added to control hepatitis B virus every three months. After three months, plasma purification will continue if hepatitis B virus DNA titer is still higher than cut-off normal value. plasma purification process lasts 2.5-3 hours each session.

Interventions

active comarator using antiviral drug of nucleoside analogues

using antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus.

Intervention Type: DRUG

HA+purification

Based on antiviral drug of nucleoside analogues, plasma purification is added to control hepatitis B virus every three months. After three months, plasma purification will continue if hepatitis B virus DNA titer is still higher than cut-off normal value. plasma purification process lasts 2.5-3 hours each session.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pudong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin HM, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Min Jin, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Hui Min Jin, MD

Role: CONTACT

hmjgli@163.com

13917232915

Xiu Hong Yang, MD

Role: CONTACT

18317070897@163.com

18317070897

Other Identifiers

ShanghaiPudongH4

Identifier Type: -

Identifier Source: org_study_id