Chronic Hepatitis BPhase 4NCT03792919
Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
A Phase 4 study testing Stop current treatment (anti-HBV neucleos(t)ides) and Keep current treatment (anti-HBV neucleos(t)ides) in people with Chronic Hepatitis B, run by Humanity & Health Medical Group Limited at 1 site in Hong Kong.
Trial summary
To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Stop current treatment (anti-HBV neucleos(t)ides) and Keep current treatment (anti-HBV neucleos(t)ides)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2018to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HBsAg positive, HBeAg negative, antibody to HBeAg-positive;
- Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year;
- Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule;
- Patients read, understand the consent form, and signed the study consent.
Who cannot join
- Patient with other liver diseases;
- Patient with concurrent hepatitis viruses or HIV infection;
- Patients are reluctant to stop their anti-HBV treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Humanity & Health Research Centre
Hong Kong, Hong Kong SAR
Danny Wang, 852-28613777, danny.wang@hnhmgl.com
About this study
Official title: Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients
To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients.
Read the detailed description
Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss rate is low even after long-term NAs treatment. Recent studies indicated that cessation of NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance is very important.
- Conditions
- Chronic Hepatitis B
- Being tested
- Stop current treatment (anti-HBV neucleos(t)ides), Keep current treatment (anti-HBV neucleos(t)ides)
- 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.
Stop current treatment (anti-HBV neucleos(t)ides)Drug
Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
Keep current treatment (anti-HBV neucleos(t)ides)Drug
Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cessation of NAs treatment | Experimental | Chronic hepatitis B patients who meet the criteria to stop the current anti-HBV Neucleos(t)ides treatment will stop their NAs at the baseline of the clinical trial. Receives: Drug: Stop current treatment (anti-HBV neucleos(t)ides) |
| Keep on current NAs treatment | Active comparator | Chronic hepatitis B patients who meet the criteria to stop anti-HBV Neucleos(t)ides treatment will choose to keep on their current NAs treatment from the baseline of the clinical trial. Receives: Drug: Keep current treatment (anti-HBV neucleos(t)ides) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HBsAg clearance
The incidence of HBsAg clearance during the off-treatment period
Measured: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Secondary outcomes (5)
Incidence of HBsAg seroconversion
The incidence of HBsAg seroconversion during the off-treatment period
Measured: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of sustain HBV viral submission
The incidence of sustain HBV viral submission during the off-treatment period
Measured: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of sustain biological response
The incidence of sustain biological response during the off-treatment period
Measured: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of hepatocellular carcinoma
The incidence of hepatocellular carcinoma during the off-treatment period
Measured: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of Liver failure
The incidence of Liver failure during the off-treatment period
Measured: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Dec 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to 2 groups. Group 1: Stop current anti-HBV neucleos(t)ides treatment, Group 2: Keep on current anti-HBV nucleus(t)ides treatment
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanity & Health Medical Group Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792919
- Sponsor's protocol ID
- VENI-1
- Status last verified
- Mar 2025
- First submitted
- 1 Jan 2019
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients
- ClinicalTrials.gov ID
- NCT03792919
- Acronym / sponsor ID
- VENI-1
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Humanity & Health Medical Group LimitedUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jan 2019 (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 Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients.
Detailed description
Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss rate is low even after long-term NAs treatment. Recent studies indicated that cessation of NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance is very important.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to 2 groups. Group 1: Stop current anti-HBV neucleos(t)ides treatment, Group 2: Keep on current anti-HBV nucleus(t)ides treatment
| Arm | Type | Receives |
|---|---|---|
| Cessation of NAs treatment | Experimental | Drug: Stop current treatment (anti-HBV neucleos(t)ides)Chronic hepatitis B patients who meet the criteria to stop the current anti-HBV Neucleos(t)ides treatment will stop their NAs at the baseline of the clinical trial. |
| Keep on current NAs treatment | Active comparator | Drug: Keep current treatment (anti-HBV neucleos(t)ides)Chronic hepatitis B patients who meet the criteria to stop anti-HBV Neucleos(t)ides treatment will choose to keep on their current NAs treatment from the baseline of the clinical trial. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- HBsAg positive, HBeAg negative, antibody to HBeAg-positive;
- Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year;
- Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule;
- Patients read, understand the consent form, and signed the study consent.
Key exclusion criteria (3 listed)
- Patient with other liver diseases;
- Patient with concurrent hepatitis viruses or HIV infection;
- Patients are reluctant to stop their anti-HBV treatment.
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 |
|---|---|---|
| Stop current treatment (anti-HBV neucleos(t)ides)Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment. | Drug | Cessation of NAs treatment |
| Keep current treatment (anti-HBV neucleos(t)ides)Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment. | Drug | Keep on current NAs treatment |
Primary outcome
Incidence of HBsAg clearance
Time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
The incidence of HBsAg clearance during the off-treatment period
5 secondary outcomes
Incidence of HBsAg seroconversion
Time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of sustain HBV viral submission
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of sustain biological response
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of hepatocellular carcinoma
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of Liver failure
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stop current treatment (anti-HBV neucleos(t)ides) and Keep current treatment (anti-HBV neucleos(t)ides) in people with Chronic Hepatitis B, run by Humanity & Health Medical Group Limited at 1 site in Hong Kong.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George Lau, MD (852-28613777, gkklau@netvigator.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HBsAg clearance (time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.). 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 24 Mar 2025.