RecruitingPhase 4NCT03792919

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

Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients


Sponsor

Humanity & Health Medical Group Limited

Enrollment

2,000 participants

Start Date

Dec 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria4

  • 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.

Exclusion Criteria3

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

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Interventions

DRUGStop 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.

DRUGKeep 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.


Locations(1)

Humanity & Health Research Centre

Hong Kong, Hong Kong SAR, Hong Kong

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NCT03792919


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