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

October 12, 2022 updated by: University Hospital, Antwerp

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium
        • Recruiting
        • ASZ Aalst
        • Contact:
          • Isabelle Colle, MD PhD
      • Antwerp, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Contact:
      • Antwerp, Belgium, 2060
        • Recruiting
        • ZNA Stuivenberg
        • Contact:
          • Stefan Bourgeois, MD
      • Antwerp, Belgium
        • Recruiting
        • GZA Antwerp
        • Contact:
          • Dirk Sprengers, MD
      • Brasschaat, Belgium
        • Recruiting
        • AZ Klina
        • Contact:
          • Jos Callens, MD
      • Brugge, Belgium
        • Recruiting
        • AZ Sint-Jan Brugge
        • Contact:
          • Hans Orlent, MD
      • Brussel, Belgium
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Peter Stärkel, MD PhD
      • Brussels, Belgium
        • Recruiting
        • CHU Brugmann
        • Contact:
          • Baro Deressa, MD
      • Brussels, Belgium
        • Recruiting
        • UZ Brussels
        • Contact:
          • Hendrik Reynaert, MD PhD
      • Brussels, Belgium
        • Recruiting
        • CHU Saint-Pierre
        • Contact:
          • Jean-Pierre Delwaide, MD
      • Brussels, Belgium
        • Recruiting
        • ULB Erasme Hospital
        • Contact:
          • Christophe Moréno, MD PhD
      • Charleroi, Belgium
        • Recruiting
        • Grand Hopital de Charleroi
        • Contact:
          • Sergio Negrin-Dastis, MD
      • Genk, Belgium
        • Recruiting
        • ZOL Genk
        • Contact:
          • Geert Robaeys, MD PhD
      • Gent, Belgium
        • Recruiting
        • UZ Gent
        • Contact:
          • Xavier Verhelst, MD PhD
      • Gent, Belgium
        • Recruiting
        • AZ Maria Middelares Gent
        • Contact:
          • Christophe Vansteenkiste, MD PhD
      • Kortrijk, Belgium
        • Recruiting
        • Az Groeninge
        • Contact:
          • Christophe George, MD
      • La Louvière, Belgium
        • Recruiting
        • Groupe Jolimont
        • Contact:
          • Marie De Vos, MD
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
        • Contact:
          • Jef Verbeek, MD PhD
      • Liège, Belgium
        • Recruiting
        • CHU Sart-Tilmann
        • Contact:
          • Jean Delwaide, MD PhD
      • Namur, Belgium
        • Recruiting
        • Clinique Saint-Luc Bouge
        • Contact:
          • Pierre Deltenre, MD PhD
      • Ostend, Belgium
        • Recruiting
        • AZ Damiaan
        • Contact:
          • Mike Cool, MD
      • Roeselare, Belgium
        • Recruiting
        • AZ Delta
        • Contact:
          • Charlotte De Vloo, MD
      • Sint-Niklaas, Belgium
        • Recruiting
        • AZ Nikolaas
        • Contact:
          • Wim Verlinden, MD PhD
      • Turnhout, Belgium
        • Recruiting
        • Az Turnhout
        • Contact:
          • Guy Van Roey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STOP: Caucasian patients
Cessation of treatment
Other: Cessation of ongoing treatment
Cessation of ongoing treatment
Experimental: STOP: non-Caucasian patients
Cessation of treatment
Other: Cessation of ongoing treatment
Cessation of ongoing treatment
No Intervention: Control group
Standard of care follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral control
Time Frame: 72 weeks
Number of participants with viral control after treatment cessation
72 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBsAg loss
Time Frame: 72 weeks
Number of participants with HBsAg loss after treatment cessation
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Universiteit Antwerpen

Investigators

  • Study Chair: Thomas Vanwolleghem, MD PhD, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Upon reasonable request and after publication of the results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis B

Clinical Trials on Cessation of ongoing treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe