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Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Summary
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),NAs-only treatment stage(12 weeks) and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-5635 Injection in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2026-07-17
Completion Date
2028-06
Last Updated
2026-07-24
Healthy Volunteers
No
Interventions
HRS-5635 Injection
HRS-5635 Injection, administered by subcutaneous injection;
Placebo
Placebo, administered by subcutaneous injection.
Locations (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangzhou, China