STOP-NUC Statististical Analysis Plan (SAP)

Version 1

For each clinical trial conducted according to the German Medicines Act (AMG) or the Medical Devices Act (MPG), a sponsor must be named who assumes overall responsibility for the clinical trial. In the case of human clinical trials initiated and managed by staff of the Medical Faculty of the University of Leipzig or Leipzig University Hospital (UKL) (Investigator Initiated Trials; IITs), the University of Leipzig assumes the function of sponsor if no third party is the sponsor.

Coordinating investigator: Prof. Dr. Florian van Bömmel Sektion Hepatologie, Klinik und Poliklinik für Gastroenterologie und Rheumatologie Universitätsklinikum Leipzig Sponsor: Universität Leipzig Ritterstr. 26, 04109 Leipzig 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 ...