Plasma Purification and Chronic Hepatitis B

Chronic Hepatitis b Clinical Trial

Official title:

Shanghai Pudong Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04518553
• Other study ID #: ShanghaiPudongH4
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2020
• Source: Shanghai Pudong Hospital
• Contact: Hui Min Jin, MD
• Phone: 13917232915
• Email: hmjgli[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: September 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of HBV(hepatitis B virus) HBeAg is serologically negative	serological examination every three months	2 years
Secondary	Concentration of HBV-DNA virus load is undetected	serological examination by compared of HAs with HAs+plasma purification treatment	2 years
Secondary	Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly	serological examination every three months	2 years
Secondary	hepatitis B virus HBsAg serological transformation is negative	serological examination every three months	2 years