Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Phase 3RecruitingNCT07606950

Fujian Shengdi Pharmaceutical Co., Ltd.540 enrolled

Overview

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks)，NAs-only treatment stage（12 weeks） and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

540

Conditions

Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening; 2. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation; 3. HBeAg negative at screening; 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. 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; 7. Laboratory tests during the screening period were obviously abnormal; 8. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period; 9. History of drug use, alcohol or drug abuse in the 12 months prior to randomization; 10. Participated in clinical study of other drugs (received experimental drugs); 11. Pregnant or nursing women; 12. Allergic to a drug ingredient or component; 13. Other reasons for ineligibility as judged by the investigators.

Outcomes

Primary Outcomes

Percentage of participants with sustained HBV DNA suppression and HBsAg loss within 24 weeks after discontinuation of all HBV therapy

Time frame: 24 weeks after discontinuation of all CHB treatment

Secondary Outcomes

Percentage of participants with sustained HBV DNA suppression and HBsAg < 100 IU/mL

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with sustained HBV DNA suppression and HBsAg < 10 IU/mL

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with sustained HBV DNA suppression

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with HBsAg < 100 IU/mL

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with HBsAg < 10 IU/mL

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Changes from baseline in mean log10 HBsAg levels

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with HBsAg loss

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with HBsAg seroconversion

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with HBeAb positive

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with virologic breakthrough

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants with drug resistance

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Percentage of participants who meet the criteria for stopping nucleos(t)ide analogue (NA) therapy

Time frame: Week 72 and Week 96

Relapse rate after discontinuation of NAs therapy

Time frame: Up to 24 weeks after discontinuation of NAs treatment

Treatment-emergent adverse events

Time frame: Up to 24 weeks after discontinuation of NAs treatment

Percentage of participants with detectable anti-drug antibodies

Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts