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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
Shanghai Pudong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    August 11, 2020
    Last Updated
    March 16, 2021
    Sponsor
    Shanghai Pudong Hospital
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    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

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    Plasma Purification and Chronic Hepatitis B

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