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Plasma Purification and Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT04518553
Recruitment Status : Not yet recruiting
First Posted : August 19, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Jin HM, MD, Shanghai Pudong Hospital

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Drug: active comarator using antiviral drug of nucleoside analogues Device: HA+purification Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shanghai Pudong Hospital
Estimated Study Start Date : March 23, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: active control
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.
 Drug: active comarator using antiviral drug of nucleoside analogues
using antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus.
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of HBV(hepatitis B virus) HBeAg is serologically negative [ Time Frame: 2 years ]
    serological examination every three months


Secondary Outcome Measures :
  1. Concentration of HBV-DNA virus load is undetected [ Time Frame: 2 years ]
    serological examination by compared of HAs with HAs+plasma purification treatment

  2. Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly [ Time Frame: 2 years ]
    serological examination every three months

  3. hepatitis B virus HBsAg serological transformation is negative [ Time Frame: 2 years ]
    serological examination every three months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518553


Contacts
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Contact: Hui Min Jin, MD 13917232915 hmjgli@163.com
Contact: Xiu Hong Yang, MD 18317070897 18317070897@163.com

Sponsors and Collaborators
Shanghai Pudong Hospital
Investigators
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Principal Investigator: Hui Min Jin, MD Fudan University
More Information
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Responsible Party: Jin HM, MD, professor, Shanghai Pudong Hospital
ClinicalTrials.gov Identifier: NCT04518553    
Other Study ID Numbers: ShanghaiPudongH4
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents