Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) and the off-treatment follow-up (24 weeks), is up to approximately 88 weeks at maximum for each participant.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-5635 Injection | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5635 Injection | Drug | HRS-5635 Injection, administered by subcutaneous injection; |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with sustained HBV DNA suppression and HBsAg loss within 24 weeks after discontinuation of all HBV therapy | 24 weeks after discontinuation of all CHB treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with sustained HBV DNA suppression and HBsAg < 100 IU/mL | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangchao Dong | Contact | 0518-82342973 | guangchao.dong.gd1@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangzhou | 510515 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo, administered by subcutaneous injection. |
|
| Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Percentage of participants with sustained HBV DNA suppression | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Percentage of participants with HBsAg < 100 IU/mL | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Percentage of participants with HBsAg < 10 IU/mL | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Changes from baseline in mean log10 HBsAg levels | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Percentage of participants with HBsAg loss | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Percentage of participants with HBsAg seroconversion | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Percentage of participants with HBeAb positive | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Percentage of participants with virologic breakthrough | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |
| Percentage of participants with drug resistance | 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 | Week 48、Week 60 and Week 84 |
| Relapse rate after discontinuation of NAs therapy | Up to 24 weeks after discontinuation of NAs treatment |
| Treatment-emergent adverse events | Up to 24 weeks after discontinuation of NAs treatment |
| Percentage of participants with detectable anti-drug antibodies | Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment |