2 projects 108 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 German STOP-NUC 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. English chronic HBeAg-negative hepatitis B 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 false true 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 false Phase-4 29151 STOP-NUC: 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 **Coordinating investigator:** Prof. Dr. Florian van Bömmel Sektion Hepatologie, Klinik und Poliklinik für Gastroenterologie und Rheumatologie Universitätsklinikum Leipzig<br> **Sponsor:** Universität Leipzig Ritterstr. 26, 04109 Leipzig<br> **Registration**: EudraCT: 2013-004882-15 DRKS: DRKS00006240 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. In 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. https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004882-15/DE CC-BY-4.0 2014-11-18 2022-01-30 1 2 3 2 12 2 14 2 7 3 1 people 3 people 7 people 1 people 3 people 12 people 14 people 7 people 2 institutions 3 institutions 1 programmes 3 publications 2 documents 3 documents /projects/2 2023-03-28T10:34:07.000Z 2024-01-31T15:17:48.000Z 0.3 https://ldh.zks.uni-leipzig.de fe4b0b80-af81-013b-12b4-32b44ecc9602 1.0