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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Stop current treatment (anti-HBV neucleos(t)ides); Drug: Keep current treatment (anti-HBV neucleos(t)ides)

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Danny Wang; Phone Number: 852-28613777; Email: danny.wang@hnhmgl.com
• Study Contact Backup: Name: George Lau, MD; Phone Number: 852-28613777; Email: gkklau@netvigator.com

Study Locations

• Hong Kong
  • Hong Kong SAR
    • Hong Kong, Hong Kong SAR, Hong Kong
      • Recruiting
      • Humanity & Health Research Centre
      • Contact: Danny Wang; Phone Number: 852-28613777; Email: danny.wang@hnhmgl.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cessation of NAs treatment; Chronic hepatitis B patients who meet the criteria to stop the current anti-HBV Neucleos(t)ides treatment will stop their NAs at the baseline of the clinical trial.	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.
Active Comparator: Keep on current NAs treatment; Chronic hepatitis B patients who meet the criteria to stop anti-HBV Neucleos(t)ides treatment will choose to keep on their current NAs treatment from the baseline of the clinical trial.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Humanity & Health Medical Group Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: VENI-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes