Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks) and the off-treatment follow-up (24 weeks), is up to approximately 88 weeks at maximum for each participant.
Chronic hepatitis B defined as HBV infection documented for at least 6 months pr... [+5]
History of cirrhosis or clinical evidence of hepatic decompensation, confirmed o... [+12]