30-50% of patients will achieve sustained virological response after discontinuation of entecavir or tenofovir
ID
Bron
Verkorte titel
Aandoening
chronic hepatitis B
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Sustained response, defined as HBV DNA < 2,000 IU/mL at week 48 after therapy discontinuation.
Achtergrond van het onderzoek
-
Doel van het onderzoek
30-50% of patients will achieve sustained virological response after discontinuation of entecavir or tenofovir
Onderzoeksproduct en/of interventie
cessation of treatment
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
„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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
„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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6814 |
| NTR-old | NTR7001 |
| Ander register | : |