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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Other: Cessation of ongoing treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STOP: Caucasian patients<br>Cessation of treatment | Other: Cessation of ongoing treatment<br>* Cessation of ongoing treatment<br>|
| Experimental: STOP: non-Caucasian patients<br>Cessation of treatment | Other: Cessation of ongoing treatment<br>* Cessation of ongoing treatment<br>|
| No Intervention: Control group<br>Standard of care follow-up | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis B