This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
127
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 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: up to 72 weeks
Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .
Time frame: Up to 72 weeks
Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.
Time frame: Up to 72 weeks
Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.
Time frame: Up to 48 weeks
Relapse rate after discontinuation of NAs therapy.
Time frame: Up to 72 weeks
Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values.
Time frame: Up to 72 weeks
Relapse time after discontinuation of NAs therapy.
Time frame: Up to 72 weeks
Plasma concentrations of AHB-137.
Time frame: Up to 48 weeks
Serum concentrations of Peg-IFN.
Time frame: Up to 48 weeks.
Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).
Time frame: Up to 72 weeks
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Safety: 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 72 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Examination including laboratory examination, electrocardiogram (ECG) examination.
Time frame: Up to 72 weeks
Safety: Monitoring the score changes of Columbia Suicide Severity Scale (CSSRS) .
The CSSRS is a categorical, interviewer-rated instrument that screens for suicidal ideation (five items, 0-1 each) and suicidal behavior (six items, 0-1 each); the highest positive item defines the risk level rather than a total score. For ideation items 3-5 an additional 0-5 intensity rating can be recorded. Across all items the minimum value is 0 (absent) and the maximum is 1 (present); a score of 1 on any item indicates a worse outcome and triggers escalating clinical safeguards, with any behavior item being tantamount to a suicidal event.
Time frame: Up to 72 weeks.
Safety: Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
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 72 weeks
Safety: Monitoring the score changes of Self-Rating Depression Scale (SDS).
The SDS is a 20-item, 4-point Likert self-report scale that yields a raw sum of 20-80 points, conventionally converted to a standard score of 25-100 by multiplying the raw total by 1.25. Higher standard scores denote worse outcomes: \<50 normal, 50-59 mild, 60-69 moderate, and ≥70 severe depression, with ≥70 warranting specialist evaluation and suicide-risk assessment.
Time frame: Up to 72 weeks.