Status:
RECRUITING
Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
Lead Sponsor:
Humanity & Health Medical Group Limited
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
Phase:
PHASE4
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.
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 inhibiti...
Eligibility Criteria
Inclusion
- 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
- Patient with other liver diseases;
- Patient with concurrent hepatitis viruses or HIV infection;
- Patients are reluctant to stop their anti-HBV treatment.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03792919
Start Date
December 1 2018
End Date
December 31 2025
Last Update
March 24 2025
Active Locations (1)
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1
Humanity & Health Research Centre
Hong Kong, Hong Kong SAR, Hong Kong