Actively Recruiting
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
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-17
369
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of HRS-5635 injection alone or combined with other treatments in adults with chronic hepatitis B who are already receiving therapy. This Phase II, multicenter, randomized, open-label study aims to better understand how these treatments affect the hepatitis B surface antigen levels in patients with this long-term liver infection. Participants will receive one of several doses of HRS-5635 injection given by subcutaneous injection, either alone or combined with Peg-IFN-α, another injected medication. The study includes multiple groups to compare different doses and combinations, with a follow-up period extending up to 72 weeks to monitor changes in virus markers and treatment response. During the study, participants will have regular blood tests to measure hepatitis B surface antigen and other viral markers at specified intervals, including weeks 12, 48, and up to 72. Researchers will also watch for any safety concerns, drug resistance, or changes in viral activity. The total time involved varies depending on the treatment group but includes long-term monitoring of virus levels and treatment effects.
CONDITIONS
Brief 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 (BMI) between 18.5 and 35 kg/m2
- Chronic hepatitis B infection documented for at least 6 months before screening
- Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation
- On stable nucleoside or nucleotide analogue monotherapy for at least 24 weeks before randomization, with no dose changes for at least 4 weeks prior
- Willing to use effective contraceptive methods
- Able to provide informed consent voluntarily
You will not qualify if you...
- History or signs 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
- Severe or uncontrolled cardiovascular or cerebrovascular diseases
- Diagnosis of malignant tumors within 5 years prior to randomization
- Infection requiring treatment within 2 weeks before randomization
- Major trauma or surgery within 12 weeks before randomization or planned interventions affecting study results
- Abnormal laboratory tests during screening
- Prolonged ECG QTcF or other serious safety risks found during screening
- History of drug, alcohol, or substance abuse within 12 months prior to randomization
- Participation in other clinical drug studies or use of experimental drugs
- Pregnant or nursing women
- Allergies to study drug ingredients
- Other reasons for ineligibility as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive HRS-5635 Injection alone or in combination with Peg-IFN-α by subcutaneous injection according to their assigned group to treat chronic hepatitis B.
Regular visits during the treatment period for injections and assessments
Duration - Up to 24 weeks after treatment
Participants are monitored for safety and efficacy outcomes after completing treatment.
Visits at pre-specified time points up to 72 weeks
Trial Site Locations
Total: 1 location
1
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
X
Xiaopeng Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here