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

Sponsor
Humanity & Health Medical Group Limited (Other)
Overall Status
Recruiting
CT.gov ID
NCT03792919
Collaborator
(none)
2,000
1
2
67
29.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Stop current treatment (anti-HBV neucleos(t)ides)
  • Drug: Keep current treatment (anti-HBV neucleos(t)ides)
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 treatmentParticipants 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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of HBsAg clearance [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 Outcome Measures

  1. Incidence of HBsAg seroconversion [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Humanity & Health Research Centre Hong Kong Hong Kong SAR Hong Kong

Sponsors and Collaborators

  • Humanity & Health Medical Group Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Humanity & Health Medical Group Limited
ClinicalTrials.gov Identifier:
NCT03792919
Other Study ID Numbers:
  • VENI-1
First Posted:
Jan 4, 2019
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022