Chronic Hepatitis B
Conditions
Keywords
Hepatitis B, Chronic
Brief summary
This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
Interventions
DRUGAHB-137
AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.
DRUGPlacebo
Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.
DRUGNA therapy
NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.
Sponsors
Ausper Biopharma 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
* Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol; * At least 18 years of age at the time of signing the ICF; * Body mass index met the requirements; * HBeAg negative at screening; * HBsAg or HBV DNA positive for at least 6 months; * Meet relevant requirements for NAs treatment; * 100 IU/mL \< HBsAg ≤ 3000 IU/mL, HBV DNA \< 100 IU/mL and liver function indicators meet the requirements; * Effective contraception as required.
Exclusion criteria
* Clinically significant abnormalities other than a history of chronic HBV infection; * Concomitant clinically significant other liver diseases; * Previous/current manifestations of hepatic decompensation; * Significant hepatic fibrosis or cirrhosis; * Presence of protocol-specified laboratory abnormalities; * History of malignancy or ongoing assessment of possible malignancy; * Those allergic to AHB-137 or its components; * Participants with recent major trauma or major surgery, or planning surgery; * Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Prior/current use of prohibited medications; * Inappropriate for participation in this trial as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued | 24 weeks after discontinuation of all CHB treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ | Up to 60 weeks | — |
| Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb | Up to 60 weeks | — |
| Relapse rate after discontinuation of NAs therapy. | Up to 60 weeks | — |
| Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA). | Up to 60 weeks | — |
| Proportion of participants with persistent HBV DNA < LLOQ . | 24 weeks after discontinuation of all CHB treatment | — |
| Plasma concentrations of AHB-137. | Up to 60 weeks | — |
| Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137 | Up to 60 weeks | — |
| Change from baseline in EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) scores in participants with HBV infection. | Up to 60 weeks | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. |
| Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline. | Up to 60 weeks | This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life. |
| Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results. | Up to 60 weeks | — |
Countries
China
Outcome results
None listed