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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
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
369
Start Date
2024-06-06
Completion Date
2027-01-19
Last Updated
2025-11-17
Healthy Volunteers
No
Conditions
Interventions
HRS-5635 Injection
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 Injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection (low dose) and Peg-IFN-α
HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection (high dose) and Peg-IFN-α
HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
Peg-IFN-α
Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection with Peg-IFN-α
HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection
HRS-5635 Injection, administered by subcutaneous injection
Locations (1)
Nanfang Hospital
Guangzhou, Guangdong, China