Clinical trial NCT04779970: COIN-B: COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
Official title: COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Hepatitis B
Keywords: Chronic Hepatitis B
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2021-03-03
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral control
timeFrame: 72 weeks
Secondary outcomes:
measure: HBsAg loss
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Antwerp
country: Belgium
facility: ZNA Stuivenberg
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Antwerp
country: Belgium
facility: GZA Antwerp
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Brussels
country: Belgium
facility: ULB Erasme Hospital
city: Brussels
country: Belgium
facility: UZ Brussels
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
city: Genk
country: Belgium
facility: ZOL Genk
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuizen
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: La Louvière
country: Belgium
facility: Groupe Jolimont
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC Liège
city: Liège
country: Belgium
facility: CHU Sart-Tilmann
city: Namur
country: Belgium
facility: Clinique Saint-Luc Bouge
city: Ostend
country: Belgium
facility: AZ Damiaan
city: Roeselare
country: Belgium
facility: AZ Delta
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: University Hospital, Antwerp
name: Thomas Vanwolleghem, MD PhD
role: STUDY_CHAIR
References: