Plasma Purification and Chronic Hepatitis B

Sponsor
Shanghai Pudong Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04518553
Collaborator
(none)
230
2
30.3

Study Details

Study Description

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
  • Drug: active comarator using antiviral drug of nucleoside analogues
  • Device: HA+purification
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
230 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Shanghai Pudong Hospital
Anticipated Study Start Date :
Mar 23, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Concentration of HBV(hepatitis B virus) HBeAg is serologically negative [2 years]

    serological examination every three months

Secondary Outcome Measures

  1. Concentration of HBV-DNA virus load is undetected [2 years]

    serological examination by compared of HAs with HAs+plasma purification treatment

  2. Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly [2 years]

    serological examination every three months

  3. hepatitis B virus HBsAg serological transformation is negative [2 years]

    serological examination every three months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Pudong Hospital

Investigators

  • Principal Investigator: Hui Min Jin, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin HM, MD, professor, Shanghai Pudong Hospital
ClinicalTrials.gov Identifier:
NCT04518553
Other Study ID Numbers:
  • ShanghaiPudongH4
First Posted:
Aug 19, 2020
Last Update Posted:
Mar 17, 2021
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2021