NCT06425341

Recruiting

Phase 2

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

Fujian Shengdi Pharmaceutical Co., Ltd.1 site in 1 country369 target enrollmentJune 6, 2024

InterventionsHRS-5635 Injection HRS-5635 Injection (low dose) and Peg-IFN-α HRS-5635 Injection (high dose) and Peg-IFN-α Peg-IFN-α HRS-5635 Injection with Peg-IFN-α

Overview

Phase: Phase 2
Intervention: HRS-5635 Injection
Conditions: Chronic Hepatitis B
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Enrollment: 369
Locations: 1
Primary Endpoint: PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 6, 2024

End Date

January 19, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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;
•With autoimmune disease;
•History of solid organ transplantation or hematopoietic stem cell transplantation;
•Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
•Malignant tumors were diagnosed within 5 years prior to randomization；
•Infection requiring intervention within 2 weeks prior to randomization;
•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;
•Laboratory tests during the screening period were obviously abnormal;
•Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
•History of drug use, alcohol or drug abuse in the 12 months prior to randomization;

Arms & Interventions

HRS-5635 Injection dose 1

Intervention: HRS-5635 Injection

HRS-5635 Injection dose 2

Intervention: HRS-5635 Injection

HRS-5635 Injection dose 3

Intervention: HRS-5635 Injection

HRS-5635 Injection dose 4

Intervention: HRS-5635 Injection

HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection

Intervention: HRS-5635 Injection (low dose) and Peg-IFN-α

HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection

Intervention: HRS-5635 Injection (high dose) and Peg-IFN-α

Peg-IFN-α, administered by subcutaneous injection

Intervention: Peg-IFN-α

HRS-5635 Injection with Peg-IFN-α（Part C）

Intervention: HRS-5635 Injection with Peg-IFN-α

HRS-5635 Injection（Part D）

Intervention: HRS-5635 Injection

Outcomes

Primary Outcomes

PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12

Time Frame: Week 12

PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48

Time Frame: Week 48

PartC：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48

Time Frame: Week 48

PartD：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48

Time Frame: Week 48

Secondary Outcomes

Changes from baseline in mean log10 serum hepatitis B surface antigen levels(Pre-specified time points up to 72 weeks)
Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen(Pre-specified time points up to 72 weeks)
Proportion of subjects with serum hepatitis B surface antigen loss(Pre-specified time points up to 72 weeks)
Proportion of subjects with serum hepatitis B surface antigen seroconversion(Pre-specified time points up to 72 weeks)
Proportion of subjects with hepatitis B e-antigen loss(Pre-specified time points up to 72 weeks)
Proportion of subjects with serum hepatitis B e-antigen seroconversion(Pre-specified time points up to 72 weeks)
Proportion of subjects with virologic breakthrough(Pre-specified time points up to 72 weeks)
Proportion of subjects with drug resistance(Pre-specified time points up to 72 weeks)
Proportion of subjects who meet the criteria for stopping NA therapy(From 48 weeks to 72 weeks)
Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss(Week 48)