Chronic Hepatitis B
Conditions
Keywords
Chronic Hepatitis B
Brief 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.
Interventions
OTHERCessation of ongoing treatment
Cessation of ongoing treatment
Sponsors
Universiteit Antwerpen
University Hospital, Antwerp
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral control | 72 weeks | Number of participants with viral control after treatment cessation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBsAg loss | 72 weeks | Number of participants with HBsAg loss after treatment cessation |
Countries
Belgium
Outcome results
None listed