No registrations found.
ID
Source
Brief title
Health condition
chronic hepatitis B
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sustained response, defined as HBV DNA < 2,000 IU/mL at week 48 after therapy discontinuation.
Secondary outcome
1. Need for retreatment (according to study protocol or treating physician)
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)
4. Relationship between sustained response at week 48 and serum levels of HBsAg at the time of treatment cessation
Background summary
-
Study objective
30-50% of patients will achieve sustained virological response after discontinuation of entecavir or tenofovir
Intervention
cessation of treatment
Inclusion criteria
„X Age 18 ¡V 65 years
„X Treatment with entecavir or tenofovir
„X Previously HBeAg-positive patients: stable HBeAg seroconversion (confirmed HBeAg seroconversion at least 6 months apart) with at least 12 months of subsequent consolidation therapy
„X HBeAg negative patients: at least 3 years of viral suppression (HBV DNA <80 IU/mL).
Exclusion criteria
„X Presence of advanced liver disease defined as advanced fibrosis or cirrhosis (METAVIR F3 or F4; based on imaging, biopsy or liver stiffness assessment)
„X History of hepatic decompensation
„X (history of) hepatocellular carcinoma
„X Other active malignancy
„X (planned) treatment with immunosuppressive agents
„X (planned) pregnancy
„X Coinfection with HIV, HCV, HDV
„X Other indication for continued nucleo(s)tide analogue therapy
„X Expected noncompliance to follow-up
„X Unwillingness to refrain from sexual activity without condom with partners who are not vaccinated against hepatitis B virus
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6814 |
| NTR-old | NTR7001 |
| Other | : |