NCT04779970

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

COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Cessation of ongoing treatment	Cessation of ongoing treatment

Timeline

• Start date: 2021-07-28
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-03-03
• Last updated: 2024-06-24

Locations

26 sites across 1 country: Belgium