Clinical trial NCT06425341: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, random, open, parallel design
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12
timeFrame: Week 12
measure: PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
timeFrame: Week 48
Secondary outcomes:
measure: Changes from baseline in mean log10 serum hepatitis B surface antigen levels
timeFrame: Pre-specified time points up to 72 weeks
measure: Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen
timeFrame: Pre-specified time points up to 72 weeks
measure: Proportion of subjects with serum hepatitis B surface antigen loss
timeFrame: Pre-specified time points up to 72 weeks
measure: Proportion of subjects with serum hepatitis B surface antigen seroconversion
timeFrame: Pre-specified time points up to 72 weeks
measure: Proportion of subjects with hepatitis B e-antigen loss
timeFrame: Pre-specified time points up to 72 weeks
measure: Proportion of subjects with serum hepatitis B e-antigen seroconversion
timeFrame: Pre-specified time points up to 72 weeks
measure: Proportion of subjects with virologic breakthrough
timeFrame: Pre-specified time points up to 72 weeks
measure: Proportion of subjects with drug resistance
timeFrame: Pre-specified time points up to 72 weeks
measure: Proportion of subjects who meet the criteria for stopping NA therapy
timeFrame: From 48 weeks to 72 weeks
measure: Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss
timeFrame: Week 48
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References: