Evaluating HRS-5635 Injection for Chronic Hepatitis B Treatment

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

This study is testing if an injection called HRS-5635 can help people with chronic hepatitis B feel better when used alone or with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 369 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06425341 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial is designed to assess the efficacy and safety of HRS-5635 injection, both alone and in combination with other agents, in patients who have been treated for chronic hepatitis B. The study is multicenter and randomized, allowing for a diverse patient population and robust data collection. Participants must have a documented history of chronic hepatitis B and be virologically suppressed on nucleoside or nucleotide analogues. The trial aims to determine if HRS-5635 can improve treatment outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic hepatitis B who have been virologically suppressed on nucleoside or nucleotide analogues for at least 24 weeks.

Not a fit: Patients with a history of cirrhosis, liver cancer, or other significant liver diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with chronic hepatitis B.

How similar studies have performed: Other studies have explored similar treatment approaches, but the specific use of HRS-5635 is novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
4. 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;
5. Need to take effective contraceptive measures；
6. Volunteer to sign an informed consent.

Exclusion Criteria:

1. 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;
2. With autoimmune disease;
3. History of solid organ transplantation or hematopoietic stem cell transplantation;
4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
5. Malignant tumors were diagnosed within 5 years prior to randomization；
6. Infection requiring intervention within 2 weeks prior to randomization;
7. 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;
8. Laboratory tests during the screening period were obviously abnormal;
9. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
10. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
11. Participated in clinical study of other drugs (received experimental drugs);
12. Pregnant or nursing women;
13. Allergic to a drug ingredient or component;
14. Other reasons for ineligibility as judged by the investigators.

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xiaopeng Wang

Conditions Chronic Hepatitis B