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

Primary Purpose

Chronic Hepatitis B

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cessation of ongoing treatment
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic Hepatitis B

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ASZ AalstRecruiting
  • ZNA StuivenbergRecruiting
  • Antwerp University HospitalRecruiting
  • GZA AntwerpRecruiting
  • AZ KlinaRecruiting
  • AZ Sint-Jan BruggeRecruiting
  • CHU BrugmannRecruiting
  • CHU Saint-PierreRecruiting
  • ULB Erasme HospitalRecruiting
  • UZ BrusselsRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • Grand Hopital de CharleroiRecruiting
  • ZOL GenkRecruiting
  • AZ Maria Middelares GentRecruiting
  • UZ GentRecruiting
  • AZ GroeningeRecruiting
  • Groupe JolimontRecruiting
  • UZ LeuvenRecruiting
  • CHU Sart-TilmannRecruiting
  • Clinique Saint-Luc BougeRecruiting
  • AZ DamiaanRecruiting
  • AZ DeltaRecruiting
  • AZ NikolaasRecruiting
  • AZ TurnhoutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

STOP: Caucasian patients

STOP: non-Caucasian patients

Control group

Arm Description

Cessation of treatment

Cessation of treatment

Standard of care follow-up

Outcomes

Primary Outcome Measures

Viral control
Number of participants with viral control after treatment cessation

Secondary Outcome Measures

HBsAg loss
Number of participants with HBsAg loss after treatment cessation

Full Information

First Posted
February 26, 2021
Last Updated
October 12, 2022
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT04779970
Brief Title
COIN-B: Controlled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
Acronym
COIN-B
Official Title
Controlled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STOP: Caucasian patients
Arm Type
Experimental
Arm Description
Cessation of treatment
Arm Title
STOP: non-Caucasian patients
Arm Type
Experimental
Arm Description
Cessation of treatment
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard of care follow-up
Intervention Type
Other
Intervention Name(s)
Cessation of ongoing treatment
Intervention Description
Cessation of ongoing treatment
Primary Outcome Measure Information:
Title
Viral control
Description
Number of participants with viral control after treatment cessation
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
HBsAg loss
Description
Number of participants with HBsAg loss after treatment cessation
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Vanwolleghem, MD PhD
Phone
+32 3 821 38 53
Email
thomas.vanwolleghem@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Arno Furquim d'Almeida, PharmD
Phone
+32 492 64 50 89
Email
arno.furquimdalmeida@uantwerpen.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Vanwolleghem, MD PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Chair
Facility Information:
Facility Name
ASZ Aalst
City
Aalst
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Colle, MD PhD
Facility Name
ZNA Stuivenberg
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Bourgeois, MD
Facility Name
Antwerp University Hospital
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Vanwolleghem, MD PhD
Phone
+32 3 821 38 53
Email
thomas.vanwolleghem@uza.be
Facility Name
GZA Antwerp
City
Antwerp
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Sprengers, MD
Facility Name
AZ Klina
City
Brasschaat
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jos Callens, MD
Facility Name
AZ Sint-Jan Brugge
City
Brugge
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Orlent, MD
Facility Name
CHU Brugmann
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baro Deressa, MD
Facility Name
CHU Saint-Pierre
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Delwaide, MD
Facility Name
ULB Erasme Hospital
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Moréno, MD PhD
Facility Name
UZ Brussels
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hendrik Reynaert, MD PhD
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Stärkel, MD PhD
Facility Name
Grand Hopital de Charleroi
City
Charleroi
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Negrin-Dastis, MD
Facility Name
ZOL Genk
City
Genk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, MD PhD
Facility Name
AZ Maria Middelares Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Vansteenkiste, MD PhD
Facility Name
UZ Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Verhelst, MD PhD
Facility Name
AZ Groeninge
City
Kortrijk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe George, MD
Facility Name
Groupe Jolimont
City
La Louvière
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie De Vos, MD
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jef Verbeek, MD PhD
Facility Name
CHU Sart-Tilmann
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Delwaide, MD PhD
Facility Name
Clinique Saint-Luc Bouge
City
Namur
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Deltenre, MD PhD
Facility Name
AZ Damiaan
City
Ostend
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Cool, MD
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte De Vloo, MD
Facility Name
AZ Nikolaas
City
Sint-Niklaas
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Verlinden, MD PhD
Facility Name
AZ Turnhout
City
Turnhout
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Van Roey, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Upon reasonable request and after publication of the results

Learn more about this trial

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

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