Chronic Hepatitis BCOIN-BNCT04779970
COIN-B: COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
A study testing Cessation of ongoing treatment in people with Chronic Hepatitis B, run by University Hospital, Antwerp at 26 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Cessation of ongoing treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 26 sitesBelgium
- Study dates
- 28 Jul 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Belgium26 sites
ASZ Aalst
Aalst
ZNA Stuivenberg
Antwerp, 2060
Antwerp University Hospital
Antwerp, 2650
GZA Antwerp
Antwerp
AZ Klina
Brasschaat
AZ Sint-Jan Brugge
Bruges
CHU Brugmann
Brussels
CHU Saint-Pierre
Brussels
Cliniques Universitaires Saint-Luc
Brussels
ULB Erasme Hospital
Brussels
UZ Brussels
Brussels
Grand Hopital de Charleroi
Charleroi
ZOL Genk
Genk
AZ Maria Middelares Gent
Ghent
UZ Gent
Ghent
Jessa Ziekenhuizen
Hasselt
AZ Groeninge
Kortrijk
Groupe Jolimont
La Louvière
UZ Leuven
Leuven
CHC Liège
Liège
CHU Sart-Tilmann
Liège
Clinique Saint-Luc Bouge
Namur
AZ Damiaan
Ostend
AZ Delta
Roeselare
AZ Nikolaas
Sint-Niklaas
AZ Turnhout
Turnhout
About this study
Official title: COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
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.
Read the 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
- Being tested
- Cessation of ongoing treatment
- Keywords
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation of ongoing treatmentOther
Cessation of ongoing treatment
| Study group | Role | What they receive |
|---|---|---|
| STOP: Caucasian patients | Experimental | Cessation of treatment Receives: Other: Cessation of ongoing treatment |
| STOP: non-Caucasian patients | Experimental | Cessation of treatment Receives: Other: Cessation of ongoing treatment |
| Control group | No intervention | Standard of care follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral control
Number of participants with viral control after treatment cessation
Measured: 72 weeks
Secondary outcomes (1)
HBsAg loss
Number of participants with HBsAg loss after treatment cessation
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start28 Jul 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Thomas Vanwolleghem, MD PhD, Study chair, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779970
- Sponsor's protocol ID
- 1.0
- Acronym
- COIN-B
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request and after publication of the results
Publications
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.
PubMed 41261561
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
- ClinicalTrials.gov ID
- NCT04779970
- Acronym / sponsor ID
- COIN-B / 1.0
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STOP: Caucasian patients | Experimental | Other: Cessation of ongoing treatmentCessation of treatment |
| STOP: non-Caucasian patients | Experimental | Other: Cessation of ongoing treatmentCessation of treatment |
| Control group | No intervention | –Standard of care follow-up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Fibrosis >F2
- Active coinfection with HCV, HDV or HIV
- Pregnancy or lactation
- Immunocompromised patients
- Ever HCC or family history of HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cessation of ongoing treatmentCessation of ongoing treatment | Other | STOP: Caucasian patients, STOP: non-Caucasian patients |
Primary outcome
Viral control
Time frame: 72 weeks
Number of participants with viral control after treatment cessation
1 secondary outcome
HBsAg loss
Time frame: 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 41261561Furquim 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.
- Individual participant dataSharing planned: No. Upon reasonable request and after publication of the results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Vanwolleghem, MD PhD study chair
University Hospital, Antwerp
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cessation of ongoing treatment in people with Chronic Hepatitis B, run by University Hospital, Antwerp at 26 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral control (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.