Plasma Purification and Chronic Hepatitis B

NCT04518553 | Unknown

• 1 other identifier: ShanghaiPudongH4
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (1)

• Concentration of HBV(hepatitis B virus) HBeAg is serologically negative

  serological examination every three months

  2 years

Secondary Outcomes (3)

• Concentration of HBV-DNA virus load is undetected

  2 years

• Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly

  2 years

• hepatitis B virus HBsAg serological transformation is negative

  2 years

Study Arms (2)

active control

ACTIVE COMPARATOR

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

active interference

EXPERIMENTAL

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

Interventions

active comarator using antiviral drug of nucleoside analogues DRUG

using antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus.

active control

HA+purification DEVICE

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.

active interference

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hypotension
• Cardiopulmonary insufficiency
• Coagulation disorders
• Heparin allergy

Sponsors & Collaborators

• Shanghai Pudong Hospital: lead

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui Min Jin, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Min Jin, MD

CONTACT

13917232915; hmjgli@163.com

Xiu Hong Yang, MD

CONTACT

18317070897; 18317070897@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 19, 2020
• Study Start: March 23, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: March 17, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share