Chronic Hepatitis B
Conditions
Keywords
Hepatitis B, Chronic
Brief summary
This study is an open-label, multicenter phase II clinical study to evaluate the efficacy and safety of AHB-137 injection in participants with CHB previously treated with NA.
Interventions
DRUGAHB-137
AHB-137 will be injected
Sponsors
Ausper Biopharma Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily participate in the study and sign the informed consent form; * 18-65 years of age (including boundary values) ; * Body mass index met the requirements; * Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months; * Meet the relevant requirements for prior medications; * HBsAg and HBV DNA and liver function indicators meet the requirements; * Effective contraception as required;
Exclusion criteria
* Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection; * Associated liver disease; * Any serious infection other than CHB infection requires intravenous anti-infective therapy; * HCV RNA positive, HIV antibody positive, syphilis positive; * Abnormal laboratory results; * Diseases associated with vascular inflammatory conditions; * QT interval corrected heart rate (Fridericia method) abnormal; * History of malignancy or ongoing assessment of possible malignancy; * History of allergies, or allergic constitution; * 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. | At the 24th week after all treatment for CHB was discontinued |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with persistent HBV DNA < LLOQ . | During the 24-week period after discontinuation of all CHB treatment | — |
| Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ). | Up to 60 weeks | — |
| Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg. | Up to 60 weeks | — |
| Relapse rate and time after discontinuation of NAs therapy. | Up to 60 weeks | — |
| Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline. | Up to 60 weeks | — |
| Number and percentage of participants with detectable anti-drug antibodies (ADA). | 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 | — |
| Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results. | Up to 60 weeks | Examination including laboratory examination, electrocardiogram (ECG) examination. |
| Plasma concentrations of AHB-137. | Up to 60 weeks | — |
| Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline. | Up to 60 weeks | — |
Countries
China
Contacts
Primary ContactLu
Outcome results
None listed