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

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

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Phase 4

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Overview

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.

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.

Eligibility

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.

Study details
    Chronic Hepatitis B

NCT03792919

Humanity & Health Medical Group Limited

27 January 2024

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