{"resource":{"ids":[{"identifier":"https:\/\/ldh.zks.uni-leipzig.de\/projects\/2","scheme":"URL","relationType":"A is identical to B"}],"classification":{"type":"Study"},"titles":[{"text":"A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response","language":"DE (German)"}],"acronyms":[{"text":"STOP-NUC","language":"EN (English)"}],"descriptions":[{"text":"Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg -negative hepatitis B, as functional cure (loss of HBsAg) is rarely achieved. Discontinuation of NUC treatment may lead to functional cure; however, to date, the evidence for this has been based on small or non-randomized clinical trials. The STOP-NUC trial was designed with the aim of increasing the HBsAg loss rate using a NUC treatment interruption approach.\\r\\n\\r\\nIn this multicenter, randomized controlled trial, 166 HBeAg-negative chronic hepatitis B patients on continuous long-term NUC treatment, with HBV DNA < 172 IU\/mL (1,000 copies\/mL) for at least 4 years, were randomized to either stop (Arm A) or continue NUC treatment (Arm B) for a 96-week observation period. In total, 158 patients were available for final analysis, 79 per arm. The primary endpoint was sustained HBsAg loss up to week 96.","language":"EN (English)"}],"keywords":[{"label":"chronic HBeAg-negative hepatitis B"}],"languages":["EN (English)"],"webpage":"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2013-004882-15\/DE","contributors":[{"nameType":"Personal","personal":{"type":"Principal investigator","givenName":"Florian","familyName":"van Bömmel"},"email":"Florian.vanBoemmel@medizin.uni-leipzig.de","phone":"+4934197 12200","affiliations":[{"name":"Universität Leipzig","address":"Liebigstraße 20, 04103 Leipzig"}]}],"idsAlternative":[{"scheme":"EudraCT","identifier":"2013-004882-15"},{"scheme":"DRKS","identifier":"DRKS00006240"}],"design":{"primaryDesign":"Interventional","studyType":{"interventional":["Unknown"]},"groupsOfDiseases":{"generally":["Certain infectious or parasitic diseases (I)"]},"administrativeInformation":{"ethicsCommitteeApproval":"Request for approval submitted, approval granted","status":"Completed: Recruitment, data collection, and data quality management completed normally"},"centers":"Multicentric","centersNumber":24,"subject":"Person","eligibilityCriteria":{"ageMin":{"number":18,"timeUnit":"Years"},"genders":["Male","Female"]},"population":{"coverage":"National","countries":["Germany"]},"dataSharingPlan":{"generally":"Yes, there is a plan to make data available","supportingInformation":["Study protocol","Statistical analysis plan"],"datashield":"No"},"interventional":{"phase":"Phase-4"}},"identifier":"29151"}}