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

Recruiting
18 - 75 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

Chronic Hepatitis B

NCT04779970

University Hospital, Antwerp

25 January 2024

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