Chronic Hepatitis b
Conditions
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.
Interventions
DRUGactive comarator using antiviral drug of nucleoside analogues
using antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus.
DEVICEHA+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.
Sponsors
Shanghai Pudong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of HBV(hepatitis B virus) HBeAg is serologically negative | 2 years | serological examination every three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly | 2 years | serological examination every three months |
| hepatitis B virus HBsAg serological transformation is negative | 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 |
Contacts
Primary ContactHui Min Jin, MD
Backup ContactXiu Hong Yang, MD
Outcome results
None listed