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

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: Active, not recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Other: Cessation of ongoing 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 (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • ASZ Aalst
  • Antwerp, Belgium, 2060
    • ZNA Stuivenberg
  • Antwerp, Belgium, 2650
    • Antwerp University Hospital
  • Antwerp, Belgium
    • GZA Antwerp
  • Brasschaat, Belgium
    • AZ Klina
  • Brugge, Belgium
    • AZ Sint-Jan Brugge
  • Brussel, Belgium
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium
    • CHU Brugmann
  • Brussels, Belgium
    • CHU Saint-Pierre
  • Brussels, Belgium
    • UZ Brussels
  • Brussels, Belgium
    • ULB Erasme Hospital
  • Charleroi, Belgium
    • Grand Hôpital de Charleroi
  • Genk, Belgium
    • ZOL GENK
  • Gent, Belgium
    • Uz Gent
  • Gent, Belgium
    • Az Maria Middelares Gent
  • Hasselt, Belgium
    • Jessa Ziekenhuizen
  • Kortrijk, Belgium
    • AZ Groeninge
  • La Louvière, Belgium
    • Groupe Jolimont
  • Leuven, Belgium
    • UZ Leuven
  • Liège, Belgium
    • CHC Liege
  • Liège, Belgium
    • CHU Sart-Tilmann
  • Namur, Belgium
    • Clinique Saint-Luc Bouge
  • Ostend, Belgium
    • AZ Damiaan
  • Roeselare, Belgium
    • AZ Delta
  • Sint-Niklaas, Belgium
    • AZ Nikolaas
  • Turnhout, Belgium
    • AZ Turnhout

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

3

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	Number of participants with viral control after treatment cessation	72 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universiteit Antwerpen
• Investigators: Study Chair: Thomas Vanwolleghem, MD PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): 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): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Hepatitis B
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• 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