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

Chronic Hepatitis B Clinical Trial

Official title: Controlled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Patients

Status Recruiting

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

• NCT number: NCT04779970
• Study type: Interventional
• Source: University Hospital, Antwerp
• Contact: Thomas Vanwolleghem, MD PhD
• Phone: +32 3 821 38 53
• Email: thomas.vanwolleghem@uza.be
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Completion date: December 2025