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

Launched by FUJIAN SHENGDI PHARMACEUTICAL CO., LTD. · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HRS-5635 injection for patients with chronic Hepatitis B, a long-lasting infection of the liver. The trial is looking to see how effective and safe this treatment is, either by itself or when combined with other medications. It is currently recruiting participants who are between 65 and 74 years old, and anyone can join regardless of gender. To be eligible, participants need to have been diagnosed with chronic Hepatitis B for at least six months and must be on a stable treatment plan for at least 24 weeks.

Participants in this trial can expect to receive either the HRS-5635 injection alone or in combination with other treatments. They will need to follow certain guidelines to ensure their safety, such as not having certain other liver diseases or serious health issues that could complicate the study. Before joining, potential participants will be asked to sign an informed consent form, which explains the study in detail. Overall, this trial is an important step in finding new ways to manage chronic Hepatitis B and could contribute to better treatments for patients in the future.

Gender

ALL

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.