https://ldh.zks.uni-leipzig.de/projects/2 URL A is identical to B Study 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 DE (German) STOP-NUC EN (English) 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. EN (English) chronic HBeAg-negative hepatitis B EN (English) https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004882-15/DE Personal Principal investigator Florian van Bömmel Florian.vanBoemmel@medizin.uni-leipzig.de +4934197 12200 Universität Leipzig

Liebigstraße 20, 04103 Leipzig

EudraCT 2013-004882-15 DRKS DRKS00006240 Interventional Unknown Certain infectious or parasitic diseases (I) Request for approval submitted, approval granted Completed: Recruitment, data collection, and data quality management completed normally Multicentric 24 Person 18 Years Male Female National Germany Yes, there is a plan to make data available Study protocol Statistical analysis plan No Phase-4 29151