Chronic Hepatitis bNCT04518553
Plasma Purification and Chronic Hepatitis B
A study testing active comarator using antiviral drug of nucleoside analogues and HA+purification in people with Chronic Hepatitis b, run by Shanghai Pudong Hospital.
Trial summary
To compare the efficacy of nucleoside analogues （HA） alone and plasma purification +HA in reducing HBV viral load. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- active comarator using antiviral drug of nucleoside analogues and HA+purification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypotension
- Cardiopulmonary insufficiency
- Coagulation disorders
- Heparin allergy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Shanghai Pudong Hospital
To compare the efficacy of nucleoside analogues （HA） alone and plasma purification +HA in reducing HBV viral load.
Read the 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.
- Conditions
- Chronic Hepatitis b
- Being tested
- active comarator using antiviral drug of nucleoside analogues, HA+purification
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active comarator using antiviral drug of nucleoside analoguesDrug
using antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus.
HA+purificationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HA+purification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HBV(hepatitis B virus) HBeAg is serologically negative
serological examination every three months
Measured: 2 years
Secondary outcomes (3)
Concentration of HBV-DNA virus load is undetected
serological examination by compared of HAs with HAs+plasma purification treatment
Measured: 2 years
Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly
serological examination every three months
Measured: 2 years
hepatitis B virus HBsAg serological transformation is negative
serological examination every three months
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start23 Mar 2021 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin HM, MD, Shanghai Pudong Hospital
- Investigators
- Hui Min Jin, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518553
- Sponsor's protocol ID
- ShanghaiPudongH4
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Pudong Hospital
- ClinicalTrials.gov ID
- NCT04518553
- Acronym / sponsor ID
- ShanghaiPudongH4
- Conditions
- Chronic Hepatitis b
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Study start
- 23 Mar 2021 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active control | Active comparator | Drug: active comarator using antiviral drug of nucleoside analoguesantiviraltherapy 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. |
| active interference | Experimental | Device: HA+purificationHA+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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Hypotension
- Cardiopulmonary insufficiency
- Coagulation disorders
- Heparin allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active comarator using antiviral drug of nucleoside analoguesusing antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus. | Drug | active control |
| HA+purificationBased 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. | Device | active interference |
Primary outcome
Concentration of HBV(hepatitis B virus) HBeAg is serologically negative
Time frame: 2 years
serological examination every three months
3 secondary outcomes
Concentration of HBV-DNA virus load is undetected
Time frame: 2 years
Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly
Time frame: 2 years
hepatitis B virus HBsAg serological transformation is negative
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Min Jin, MD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing active comarator using antiviral drug of nucleoside analogues and HA+purification in people with Chronic Hepatitis b, run by Shanghai Pudong Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Min Jin, MD (13917232915, hmjgli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of HBV(hepatitis B virus) HBeAg is serologically negative (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021; AzTrials last refreshed its copy on 28 Oct 2026.