Actively Recruiting
A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-17
369
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.
CONDITIONS
Official Title
A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index between 18.5 and 35 kg/m2
- Chronic hepatitis B infection documented for at least 6 months prior to screening
- Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below quantitation limit
- On stable nucleoside or nucleotide analogues monotherapy for at least 24 weeks before randomization, with no dose changes for at least 4 weeks
- Must use effective contraceptive measures
- Volunteered and signed informed consent
You will not qualify if you...
- History or evidence of cirrhosis, liver decompensation, liver cancer, or other liver diseases affecting study evaluation
- Presence of autoimmune disease
- History of solid organ or hematopoietic stem cell transplantation
- Unstable or uncontrolled severe cardiovascular or cerebrovascular diseases
- Diagnosis of malignant tumors within 5 years prior to randomization
- Infection requiring treatment within 2 weeks prior to randomization
- Major trauma or surgery within 12 weeks prior to randomization or planned during study
- Abnormal laboratory tests during screening
- Prolonged ECG QTcF or other significant abnormal safety risks during screening
- History of drug use or alcohol/drug abuse within 12 months prior to randomization
- Participation in other clinical drug studies or received experimental drugs
- Pregnant or nursing women
- Allergy to any drug ingredient or component
- Other investigator-determined reasons for ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
X
Xiaopeng Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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