Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Conditions
Brief summary
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.
Interventions
HRS-5635 Injection, administered by subcutaneous injection;
DRUGPlacebo
Placebo, administered by subcutaneous injection.
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | 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 (NA) therapy | Week 72 and Week 96 |
| 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 |
Countries
China
Contacts
CONTACTXiaopeng Wang
Outcome results
None listed