Tests HRS-5635 injection in people with chronic hepatitis B
Tests HRS-5635 injection against placebo in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
Where in China
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Trial code
- NCT07606950
- Record updated
- 24 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening; Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation; HBeAg negative at screening; On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization; Need to take effective contraceptive measures；; Volunteer to sign an informed consent.
Exclusion: Malignant tumors were diagnosed within 5 years prior to randomization；; Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results; History of drug use, alcohol or drug abuse in the 12 months prior to randomization; Participated in clinical study of other drugs (received experimental drugs); History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study; With autoimmune disease; History of solid organ transplantation or hematopoietic stem cell transplantation; Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases; Allergic to a drug ingredient or component; Laboratory tests during the screening period were obviously abnormal; Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period; Pregnant or nursing women; Other reasons for ineligibility as judged by the investigators.