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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04518553
Other study ID # ShanghaiPudongH4
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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