Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
Primary Purpose
Chronic Hepatitis B
Status
Recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Stop current treatment (anti-HBV neucleos(t)ides)
Keep current treatment (anti-HBV neucleos(t)ides)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
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.
Sites / Locations
- Humanity & Health Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cessation of NAs treatment
Keep on current NAs treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incidence of HBsAg clearance
The incidence of HBsAg clearance during the off-treatment period
Secondary Outcome Measures
Incidence of HBsAg seroconversion
The incidence of HBsAg seroconversion during the off-treatment period
Incidence of sustain HBV viral submission
The incidence of sustain HBV viral submission during the off-treatment period
Incidence of sustain biological response
The incidence of sustain biological response during the off-treatment period
Incidence of hepatocellular carcinoma
The incidence of hepatocellular carcinoma during the off-treatment period
Incidence of Liver failure
The incidence of Liver failure during the off-treatment period
Full Information
NCT ID
NCT03792919
First Posted
January 1, 2019
Last Updated
October 2, 2023
Sponsor
Humanity & Health Medical Group Limited
1. Study Identification
Unique Protocol Identification Number
NCT03792919
Brief Title
Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanity & Health Medical Group Limited
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to 2 groups. Group 1: Stop current anti-HBV neucleos(t)ides treatment, Group 2: Keep on current anti-HBV nucleus(t)ides treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cessation of NAs treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Keep on current NAs treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Stop current treatment (anti-HBV neucleos(t)ides)
Intervention Description
Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
Intervention Type
Drug
Intervention Name(s)
Keep current treatment (anti-HBV neucleos(t)ides)
Intervention Description
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 Outcome Measure Information:
Title
Incidence of HBsAg clearance
Description
The incidence of HBsAg clearance during the off-treatment period
Time Frame
From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Secondary Outcome Measure Information:
Title
Incidence of HBsAg seroconversion
Description
The incidence of HBsAg seroconversion during the off-treatment period
Time Frame
From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Title
Incidence of sustain HBV viral submission
Description
The incidence of sustain HBV viral submission during the off-treatment period
Time Frame
rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Title
Incidence of sustain biological response
Description
The incidence of sustain biological response during the off-treatment period
Time Frame
rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Title
Incidence of hepatocellular carcinoma
Description
The incidence of hepatocellular carcinoma during the off-treatment period
Time Frame
rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Title
Incidence of Liver failure
Description
The incidence of Liver failure during the off-treatment period
Time Frame
rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Lau, MD
Phone
852-28613777
Email
gkklau@netvigator.com
First Name & Middle Initial & Last Name or Official Title & Degree
Danny Wang
Phone
852-28613777
Email
danny.wang@hnhmgl.com
Facility Information:
Facility Name
Humanity & Health Research Centre
City
Hong Kong
State/Province
Hong Kong SAR
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Wang
Phone
852-28613777
Email
danny.wang@hnhmgl.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
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