Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)

NCT ID: NCT03792919

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cessation of NAs treatment

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.

Group Type EXPERIMENTAL

Stop current treatment (anti-HBV neucleos(t)ides)

Intervention Type 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 on current NAs treatment

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.

Group Type ACTIVE_COMPARATOR

Keep current treatment (anti-HBV neucleos(t)ides)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. HBsAg positive, HBeAg negative, antibody to HBeAg-positive;
2. Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year;
3. Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule;
4. Patients read, understand the consent form, and signed the study consent.

Exclusion Criteria

1. Patient with other liver diseases;
2. Patient with concurrent hepatitis viruses or HIV infection;
3. Patients are reluctant to stop their anti-HBV treatment.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanity & Health Medical Group Limited

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Humanity & Health Research Centre

Hong Kong, Hong Kong SAR, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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George Lau, MD

Role: CONTACT

852-28613777

Danny Wang

Role: CONTACT

852-28613777

Facility Contacts

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Danny Wang

Role: primary

852-28613777

Other Identifiers

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VENI-1

Identifier Type: -

Identifier Source: org_study_id

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