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SNAP study


- candidate number27474
- NTR NumberNTR7001
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jun-2017
- Secondary IDs 
- Public TitleSNAP study
- Scientific TitleSUSTAINED RESPONSE TO NUCLEO(S)TIDE ANALOGUES FOR CHRONIC HEPATITIS B: SNAP STUDY
- ACRONYMSNAP study
- hypothesis30-50% of patients will achieve sustained virological response after discontinuation of entecavir or tenofovir
- Healt Condition(s) or Problem(s) studiedChronic hepatitis B
- Inclusion criteriaX 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 criteriaX 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2017
- planned closingdate1-sep-2019
- Target number of participants100
- Interventionscessation of treatment
- Primary outcomeSustained response, defined as HBV DNA < 2,000 IU/mL at week 48 after therapy discontinuation.
- Secondary outcome1. 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
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Milan Sonneveld
- CONTACT for SCIENTIFIC QUERIES Milan Sonneveld
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications-
- Brief summary-
- Main changes (audit trail)Ontbrekende informatie niet aangeleverd door onderzoeker.
- RECORD29-jun-2017 - 8-feb-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl