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

NCT ID: NCT04779970

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2025-12-31

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STOP: Caucasian patients

Cessation of treatment

Group Type: EXPERIMENTAL

Cessation of ongoing treatment

Intervention Type: OTHER

Cessation of ongoing treatment

STOP: non-Caucasian patients

Cessation of treatment

Group Type: EXPERIMENTAL

Cessation of ongoing treatment

Intervention Type: OTHER

Cessation of ongoing treatment

Control group

Standard of care follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cessation of ongoing treatment

Cessation of ongoing treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Vanwolleghem, MD PhD

Role: STUDY_CHAIR

University Hospital, Antwerp

Locations

ASZ Aalst

Aalst, , Belgium

ZNA Stuivenberg

Antwerp, , Belgium

Antwerp University Hospital

Antwerp, , Belgium

GZA Antwerp

Antwerp, , Belgium

AZ Klina

Brasschaat, , Belgium

AZ Sint-Jan Brugge

Bruges, , Belgium

CHU Brugmann

Brussels, , Belgium

CHU Saint-Pierre

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

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

Ghent, , Belgium

UZ Gent

Ghent, , Belgium

Jessa Ziekenhuizen

Hasselt, , Belgium

AZ Groeninge

Kortrijk, , Belgium

Groupe Jolimont

La Louvière, , Belgium

UZ Leuven

Leuven, , Belgium

CHC Liège

Liège, , 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, , Belgium

Countries

Belgium

Other Identifiers

1.0

Identifier Type: -

Identifier Source: org_study_id