Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conference

• Published in: Journal of hepatology Vol. 72; no. 3; pp. 539 - 557
• Main Authors: Cornberg, Markus, Lok, Anna Suk-Fong, Terrault, Norah A., Zoulim, Fabien, Berg, Thomas, Brunetto, Maurizia R., Buchholz, Stephanie, Buti, Maria, Chan, Henry L.Y., Chang, Kyong-Mi, Dandri, Maura, Dusheiko, Geoffrey, Feld, Jordan J., Ferrari, Carlo, Ghany, Marc, Janssen, Harry L.A., Kennedy, Patrick, Lampertico, Pietro, Liang, Jake, Locarnini, Stephen, Maini, Mala K., Mishra, Poonam, Papatheodoridis, George, Petersen, Jörg, Schlottmann, Silke, Wang, Su, Wedemeyer, Heiner
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.03.2020; Elsevier Science Ltd
• Subjects: Alanine; Alanine transaminase; Alanine Transaminase - blood; Antiviral Agents - therapeutic use; Antiviral therapy; Bilirubin; Biomarkers - blood; Clinical trials; Clinical Trials, Phase III as Topic - methods; Coinfection - blood; Coinfection - drug therapy; Coinfection - virology; CpAM; Deoxyribonucleic acid; DNA; DNA, Viral - blood; Hepatitis; Hepatitis B; Hepatitis B e antigen; Hepatitis B surface antigen; Hepatitis B Surface Antigens - blood; Hepatitis B virus - genetics; Hepatitis B virus - immunology; Hepatitis B, Chronic - blood; Hepatitis B, Chronic - drug therapy; Hepatitis B, Chronic - virology; Hepatitis D; Hepatitis D, Chronic - blood; Hepatitis D, Chronic - drug therapy; Hepatitis D, Chronic - virology; Hepatitis Delta Virus - genetics; Humans; Immunomodulatory therapy; Nucleos(t)ide analogues; Patients; Research Design; Ribonucleic acid; RNA; Sustained Virologic Response; CpAM; Antiviral therapy; Nucleos(t)ide analogues; Immunomodulatory therapy; Hepatitis B surface antigen; Hepatitis D

Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to ‘cure’ HBV. Agreement among the conference participants was reached on some key...