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NCT Number: NCT03792919

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of HBsAg clearance

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

    The incidence of HBsAg clearance during the off-treatment period

Secondary outcomes

  1. Incidence of HBsAg seroconversion

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

    The incidence of HBsAg seroconversion during the off-treatment period

  2. Incidence of sustain HBV viral submission

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

    The incidence of sustain HBV viral submission during the off-treatment period

  3. Incidence of sustain biological response

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

    The incidence of sustain biological response during the off-treatment period

  4. Incidence of hepatocellular carcinoma

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

    The incidence of hepatocellular carcinoma during the off-treatment period

  5. Incidence of Liver failure

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

    The incidence of Liver failure during the off-treatment period

Study contacts

Contact information is provided by the study sponsor or research team.

Danny Wang

CONTACT

[email protected]

852-28613777

George Lau, MD

CONTACT

[email protected]

852-28613777

Sponsors and collaborators

Lead sponsor

Humanity & Health Medical Group Limited

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2019
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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