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

Chronic Hepatitis B Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792919
• Other study ID #: VENI-1
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Humanity & Health Medical Group Limited
• Contact: George Lau, MD
• Phone: 852-28613777
• Email: gkklau[@]netvigator.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Stop 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.
• Keep 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

Country	Name	City	State
Hong Kong	Humanity & Health Research Centre	Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Humanity & Health Medical Group Limited

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of HBsAg seroconversion	The incidence of HBsAg seroconversion during the off-treatment period	From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Secondary	Incidence of sustain HBV viral submission	The incidence of sustain HBV viral submission during the off-treatment period	rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Secondary	Incidence of sustain biological response	The incidence of sustain biological response during the off-treatment period	rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Secondary	Incidence of hepatocellular carcinoma	The incidence of hepatocellular carcinoma during the off-treatment period	rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Secondary	Incidence of Liver failure	The incidence of Liver failure during the off-treatment period	rom baseline to the end of the fifth year after cessation of anti-HBV treatment.