COIN-B: Controlled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections

Chronic Hepatitis B Clinical Trial

— COIN-B  

Official title:

Controlled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779970
• Other study ID #: 1.0
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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