COIN-B: COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
COIN-B
COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
1 other identifier
interventional
156
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2021
CompletedFirst Posted
Study publicly available on registry
March 3, 2021
CompletedStudy Start
First participant enrolled
July 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 24, 2024
March 1, 2024
4.3 years
February 26, 2021
June 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Viral control
Number of participants with viral control after treatment cessation
72 weeks
Secondary Outcomes (1)
HBsAg loss
72 weeks
Study Arms (3)
STOP: Caucasian patients
EXPERIMENTALCessation of treatment
STOP: non-Caucasian patients
EXPERIMENTALCessation of treatment
Control group
NO INTERVENTIONStandard of care follow-up
Interventions
Cessation of ongoing treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Universiteit Antwerpencollaborator
Study Sites (26)
ASZ Aalst
Aalst, Belgium
ZNA Stuivenberg
Antwerp, 2060, Belgium
Antwerp University Hospital
Antwerp, 2650, 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
Related Publications (1)
Furquim d'Almeida A, Vanderlinden A, Bourgeois S, Mulkay JP, Serste T, Struyve M, Deressa B, Sprengers D, de Vos M, Callens J, Shihao B, Reynaert H, Deltenre P, Janssens F, Negrin-Dastis S, Starkel P, Orlent H, Van Roey G, Verhelst X, Moreno C, Delwaide J, Van Steenkiste C, Verlinden W, Colle I, Plissonnier ML, Mukadi BK, Testoni B, Zoulim F, Matheeussen V, Vanwolleghem T. Clinical Trial: Hepatitis B Virus Genotype and a Combination of End-of-Treatment Biomarkers Predict Severe Flares After Nucleos(t)ide Analogue Cessation. Aliment Pharmacol Ther. 2026 Feb;63(3):352-361. doi: 10.1111/apt.70465. Epub 2025 Nov 19.
PMID: 41261561DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thomas Vanwolleghem, MD PhD
University Hospital, Antwerp
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 3, 2021
Study Start
July 28, 2021
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
June 24, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
Upon reasonable request and after publication of the results