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

Not Applicable

Active, not recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Other: Cessation of ongoing treatment

• Registration Number: NCT04779970
• Lead Sponsor: University Hospital, Antwerp

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.

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-03
• Study Start: 2021-07-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 156

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STOP: Caucasian patients	Cessation of ongoing treatment	Cessation of treatment
STOP: non-Caucasian patients	Cessation of ongoing treatment	Cessation of treatment

Primary Outcome Measures

Name	Time	Method
Viral control	72 weeks	Number of participants with viral control after treatment cessation

Secondary Outcome Measures

Name	Time	Method
HBsAg loss	72 weeks	Number of participants with HBsAg loss after treatment cessation

Trial Locations

Locations (26)

ZNA Stuivenberg; 🇧🇪 Antwerp, Belgium

CHU Brugmann; 🇧🇪 Brussels, Belgium

Groupe Jolimont; 🇧🇪 La Louvière, Belgium

CHC Liège; 🇧🇪 Liège, Belgium

AZ Turnhout; 🇧🇪 Turnhout, Belgium

AZ Maria Middelares Gent; 🇧🇪 Gent, Belgium

AZ Sint-Jan Brugge; 🇧🇪 Brugge, Belgium

CHU Saint-Pierre; 🇧🇪 Brussels, Belgium

ULB Erasme Hospital; 🇧🇪 Brussels, Belgium

GZA Antwerp; 🇧🇪 Antwerp, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

ASZ Aalst; 🇧🇪 Aalst, Belgium

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium

UZ Brussels; 🇧🇪 Brussels, Belgium

CHU Sart-Tilmann; 🇧🇪 Liège, Belgium

AZ Damiaan; 🇧🇪 Ostend, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

Clinique Saint-Luc Bouge; 🇧🇪 Namur, Belgium

Jessa Ziekenhuizen; 🇧🇪 Hasselt, Belgium

AZ Klina; 🇧🇪 Brasschaat, Belgium

ZOL Genk; 🇧🇪 Genk, Belgium

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussel, Belgium

Grand Hopital de Charleroi; 🇧🇪 Charleroi, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium