SNAP study
- Conditions
- chronic hepatitis B
- Registration Number
- NL-OMON27630
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
„XAge 18 ¡V 65 years
„XTreatment with entecavir or tenofovir
Exclusion Criteria
„XPresence of advanced liver disease defined as advanced fibrosis or cirrhosis (METAVIR F3 or F4; based on imaging, biopsy or liver stiffness assessment)
„XHistory of hepatic decompensation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained response, defined as HBV DNA < 2,000 IU/mL at week 48 after therapy discontinuation.
- Secondary Outcome Measures
Name Time Method 1. Need for retreatment (according to study protocol or treating physician)<br /><br>2. HBsAg clearance at week 48. Occurrence of signs of liver failure (defined as bilirubin > 1.5 x the upper limit of normal and/or INR > 1.5)<br /><br>4. Relationship between sustained response at week 48 and serum levels of HBsAg at the time of treatment cessation<br>