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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

ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-5635 Injection

    Drug

    HRS-5635 Injection low dose administered by subcutaneous injection

  • HRS-5635 Injection

    Drug

    HRS-5635 Injection medium dose administered by subcutaneous injection

  • HRS-5635 Injection

    Drug

    HRS-5635 Injection high dose administered by subcutaneous injection

  • HRS-5635 Injection

    Drug

    HRS-5635 Injection lowest dose administered by subcutaneous injection

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

    Drug

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

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

    Drug

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

  • Peg-IFN-α

    Drug

    Peg-IFN-α, administered by subcutaneous injection

  • HRS-5635 Injection with Peg-IFN-α

    Drug

    HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection

  • HRS-5635 Injection

    Drug

    HRS-5635 Injection, administered by subcutaneous injection

Treatment groups

369 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: HRS-5635 Injection dose 1Experimental treatment 1 intervention
Group B: HRS-5635 Injection dose 2Experimental treatment 1 intervention
Group C: HRS-5635 Injection dose 3Experimental treatment 1 intervention
Group D: HRS-5635 Injection dose 4Experimental treatment 1 intervention
Group E: HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injectionExperimental treatment 1 intervention
Group F: HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injectionExperimental treatment 1 intervention
Group G: Peg-IFN-α, administered by subcutaneous injectionPlacebo comparator 1 intervention
Group H: HRS-5635 Injection with Peg-IFN-α（Part C）Experimental treatment 1 intervention
Group I: HRS-5635 Injection（Part D）Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Week 12
2

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

Time frame
Week 48
3

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

Time frame
Week 48
4

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

Time frame
Week 48

Secondary outcomes

1

Changes from baseline in mean log10 serum hepatitis B surface antigen levels

Time frame
Pre-specified time points up to 72 weeks
2

Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen

Time frame
Pre-specified time points up to 72 weeks
3

Proportion of subjects with serum hepatitis B surface antigen loss

Time frame
Pre-specified time points up to 72 weeks
4

Proportion of subjects with serum hepatitis B surface antigen seroconversion

Time frame
Pre-specified time points up to 72 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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