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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04779970
Other study ID # 1.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 28, 2021
Est. completion date December 2025

Study information

Verified date October 2022
Source University Hospital, Antwerp
Contact Thomas Vanwolleghem, MD PhD
Phone +32 3 821 38 53
Email thomas.vanwolleghem@uza.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study we will prospectively stop NA in both Caucasian and non-Caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.


Description:

An estimated 290 million people worldwide are chronically infected with the Hepatitis B Virus (HBV). One fourth of untreated patients develop progressive liver damage and are at risk of liver-related death, which can be prevented by treatment with Nucleos(t)ide Analogues (NA). These drugs efficiently suppress viral replication, but seroclearance of the virus, defined as loss of Hepatitis B surface Antigen (HBsAg), is predicted to require an average of 36 to 52 years of treatment. Cessation of NA after long-term viral suppression in patients without HBV seroclearance might reduce costs and may even increase the chance of subsequent HBsAg loss. We have recently shown in a retrospective multicentric international study, that Caucasian ethnicity and off-treatment viral control are associated with HBsAg loss after NA cessation. In this study we will prospectively stop NA in both Caucasian and non-Caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Chronic hepatitis B - Under continuous NA treatment - >= 18 years old and <= 75 years - HBeAg negative at start of treatment - HBV DNA undetectable >36 months or <100 IU/mL >48 months - ALT <= 80 U/L Exclusion Criteria: - Fibrosis >F2 - Active coinfection with HCV, HDV or HIV - Pregnancy or lactation - Immunocompromised patients - Ever HCC or family history of HCC - Ever participated in HBV siRNA therapeutic trials

Study Design


Intervention

Other:
Cessation of ongoing treatment
Cessation of ongoing treatment

Locations

Country Name City State
Belgium ASZ Aalst Aalst
Belgium Antwerp University Hospital Antwerp
Belgium GZA Antwerp Antwerp
Belgium ZNA Stuivenberg Antwerp
Belgium AZ Klina Brasschaat
Belgium AZ Sint-Jan Brugge Brugge
Belgium Cliniques Universitaires Saint-Luc Brussel
Belgium CHU Brugmann Brussels
Belgium CHU Saint-Pierre Brussels
Belgium ULB Erasme Hospital Brussels
Belgium UZ Brussels Brussels
Belgium Grand Hopital de Charleroi Charleroi
Belgium ZOL Genk Genk
Belgium AZ Maria Middelares Gent Gent
Belgium UZ Gent Gent
Belgium AZ Groeninge Kortrijk
Belgium Groupe Jolimont La Louvière
Belgium UZ Leuven Leuven
Belgium CHU Sart-Tilmann Liège
Belgium Clinique Saint-Luc Bouge Namur
Belgium AZ Damiaan Ostend
Belgium AZ Delta Roeselare
Belgium AZ Nikolaas Sint-Niklaas
Belgium AZ Turnhout Turnhout

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Antwerp Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Viral control Number of participants with viral control after treatment cessation 72 weeks
Secondary HBsAg loss Number of participants with HBsAg loss after treatment cessation 72 weeks
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