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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04779970
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
University Hospital, Antwerp

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Other: Cessation of ongoing treatment Not Applicable

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 (2, 3). 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Patients - a Cost-benefit Analysis and Assessment of the Role of Ethnicity
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Caucasian patients
Cessation of treatment
 Other: Cessation of ongoing treatment
Cessation of ongoing treatment
Active Comparator: non-Caucasian patients
Cessation of treatment
 Other: Cessation of ongoing treatment
Cessation of ongoing treatment


Outcome Measures
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Primary Outcome Measures :
  1. sustained viral control at week 72 after cessation [ Time Frame: 72 weeks ]
    sustained viral control at week 72 after cessation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis B: HBsAg+ or HBV DNA+ >6 months
  • Under continuous NA treatment (Lamivudin, Adefovir, Tenofovir or Entecavir)
  • >18 years old
  • HBeAg negative at start of treatment
  • HBV DNA undetectable >36 months or <100 IU/mL >48 months

Exclusion Criteria:

  • Fibrosis >F2 at pre-treatment start biopsy and/or fibrosis >F2 at any Fibroscan/ShearWave (unless they agree for a new biopsy)
  • Coïnfection: Hepatitis C, hepatitis delta, HIV
  • Chronic immune suppressive medication
  • Ever HCC
  • Ever participated in HBV siRNA therapeutic trials
  • Participation in other HBV therapeutic intervention studies <6 months before inclusion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779970


Contacts
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Contact: Thomas Vanwolleghem, MD PhD +32 3 281 38 53 thomas.vanwolleghem@uza.be
Contact: Arno Furquim d'Almeida, PharmD +32 3 265 26 89 arno.furquimdalmeida@uantwerpen.be

Locations
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Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Investigators
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Study Chair: Thomas Vanwolleghem, MD PhD University Hospital, Antwerp
More Information
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Responsible Party: University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT04779970    
Other Study ID Numbers: 1.0
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon publication of the findings
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Upon publication of the findings
Access Criteria: Through request to the study chair, prof. dr. Thomas Vanwolleghem

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Antwerp:
Chronic Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections