Plasma Purification and Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis b
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active comarator using antiviral drug of nucleoside analogues
HA+purification
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis b
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Chronic hepatitis B Disease
- hepatitis B virus HBeAg is positive
- hepatitis B virus HBV-DNA virus load is more than 100000cps/ml
Exclusion Criteria:
- Hypotension
- Cardiopulmonary insufficiency
- Coagulation disorders
- Heparin allergy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
active control
active interference
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Concentration of HBV(hepatitis B virus) HBeAg is serologically negative
serological examination every three months
Secondary Outcome Measures
Concentration of HBV-DNA virus load is undetected
serological examination by compared of HAs with HAs+plasma purification treatment
Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly
serological examination every three months
hepatitis B virus HBsAg serological transformation is negative
serological examination every three months
Full Information
NCT ID
NCT04518553
First Posted
August 11, 2020
Last Updated
March 16, 2021
Sponsor
Shanghai Pudong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04518553
Brief Title
Plasma Purification and Chronic Hepatitis B
Official Title
Shanghai Pudong Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2021 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pudong Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
active interference
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
active comarator using antiviral drug of nucleoside analogues
Intervention Description
using antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus.
Intervention Type
Device
Intervention Name(s)
HA+purification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Concentration of HBV(hepatitis B virus) HBeAg is serologically negative
Description
serological examination every three months
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Concentration of HBV-DNA virus load is undetected
Description
serological examination by compared of HAs with HAs+plasma purification treatment
Time Frame
2 years
Title
Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly
Description
serological examination every three months
Time Frame
2 years
Title
hepatitis B virus HBsAg serological transformation is negative
Description
serological examination every three months
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Chronic hepatitis B Disease
hepatitis B virus HBeAg is positive
hepatitis B virus HBV-DNA virus load is more than 100000cps/ml
Exclusion Criteria:
Hypotension
Cardiopulmonary insufficiency
Coagulation disorders
Heparin allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Min Jin, MD
Phone
13917232915
Email
hmjgli@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiu Hong Yang, MD
Phone
18317070897
Email
18317070897@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Min Jin, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Plasma Purification and Chronic Hepatitis B
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