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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
577
AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.
Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.
NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.
AusperBio Investigational Site
Hefei, Anhui, China
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
Time frame: 24 weeks after discontinuation of all CHB treatment
Proportion of participants with persistent HBV DNA < LLOQ .
Time frame: 24 weeks after discontinuation of all CHB treatment
Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ
Time frame: Up to 60 weeks
Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb
Time frame: Up to 60 weeks
Relapse rate after discontinuation of NAs therapy.
Time frame: Up to 60 weeks
Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).
Time frame: Up to 60 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Time frame: Up to 60 weeks
Plasma concentrations of AHB-137.
Time frame: 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
Time frame: Up to 60 weeks
Change from baseline in EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) scores in participants with HBV infection.
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AusperBio Investigational Site
Beijing, Beijing Municipality, China
AusperBio Investigational Site
Chongqing, Chongqing Municipality, China
AusperBio Investigational Site
Fuzhou, Fujian, China
AusperBio Investigational Site
Xiamen, Fujian, China
AusperBio Investigational Site
Lanzhou, Gansu, China
AusperBio Investigational Site
Foshan, Guangdong, China
AusperBio Investigational Site
Guangzhou, Guangdong, China
AusperBio Investigational Site
Shenzhen, Guangdong, China
AusperBio Investigational Site
Liuchow, Guangxi, China
...and 18 more locations
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.
Time frame: Up to 60 weeks
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
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.
Time frame: Up to 60 weeks