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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03792919
Other study ID # VENI-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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.
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