NCT03792919

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

7.1 years

First QC Date

January 1, 2019

Last Update Submit

March 21, 2025

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Incidence of HBsAg clearance

    The incidence of HBsAg clearance during the off-treatment period

    From baseline to the end of the fifth year after cessation of anti-HBV treatment.

Secondary Outcomes (5)

  • Incidence of HBsAg seroconversion

    From baseline to the end of the fifth year after cessation of anti-HBV treatment.

  • Incidence of sustain HBV viral submission

    rom baseline to the end of the fifth year after cessation of anti-HBV treatment.

  • Incidence of sustain biological response

    rom baseline to the end of the fifth year after cessation of anti-HBV treatment.

  • Incidence of hepatocellular carcinoma

    rom baseline to the end of the fifth year after cessation of anti-HBV treatment.

  • Incidence of Liver failure

    rom baseline to the end of the fifth year after cessation of anti-HBV treatment.

Study Arms (2)

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.

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.

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

Interventions

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.

Cessation of NAs 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.

Keep on current NAs treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient with other liver diseases;
  • Patient with concurrent hepatitis viruses or HIV infection;
  • Patients are reluctant to stop their anti-HBV treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanity & Health Research Centre

Hong Kong, Hong Kong SAR, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

George Lau, MD

CONTACT

852-28613777gkklau@netvigator.com

Danny Wang

CONTACT

852-28613777danny.wang@hnhmgl.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2019

First Posted

January 4, 2019

Study Start

December 1, 2018

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)