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This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHB-137 | Experimental | AHB-137 will be administered subcutaneously. |
|
| Placebo | Placebo Comparator | Placebo will be administered subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-137 | Drug | AHB-137 will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment. | Up to 48 weeks. | |
| Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment. | Up to 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment. | Up to 48 weeks. | |
| HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment. | Up to 48 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu | Contact | 0571-86959519 | clinicaltrial@ausperbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Yunqing Qiu | Zhejiang University | Principal Investigator |
| Peng Hu | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China | |||
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Placebo |
| Drug |
Placebo will be administered subcutaneously. |
|
| HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment. | Up to 48 weeks. |
| HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment. | HBsAg seroconversion : serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L. | Up to 48 weeks. |
| HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment. | HBeAg seroconversion:HBeAg negative, with simultaneous or subsequent positivity for HBeAb. | Up to 48 weeks. |
| Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment. | Up to 48 weeks. |
| HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit. | Up to 48 weeks. |
| HBsAg, HBeAg seroconversion rates by visit. | HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L. HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb. | Up to 48 weeks. |
| Test Values of Virological Parameters. | HBsAb, HBsAg, HBV DNA values and changes from baseline at each visit. | Up to 48 weeks. |
| Time to first achievement of HBsAg and first HBeAg seroconversion. | HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L. HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb. | Up to 48 weeks. |
| Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline. | Response options range from 1 to 5 with higher scores indicating more severe impact . | Up to 48 weeks. |
| 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 participant's health state. | Up to 48 weeks. |
| Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA. | Up to 48 weeks. |
| Change from baseline in alanine aminotransferase (ALT) and noninvasive assessment of liver fibrosis at each visit. | Up to 48 weeks. |
| Time to normalization of ALT without rescue therapy (for participants with abnormal baseline ALT). | Up to 48 weeks. |
| AHB-137 resistance analysis. | Method: Sequencing of HBV DNA/RNA. | Up to 48 weeks. |
| Proportion of participants who are HBeAb positive and HBeAg negative, and the test values of HBsAb, HBsAg and HBV DNA meet certain conditions. | Up to 48 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. | Up to 48 weeks. |
| Proportion of participants with positive anti-drug antibody (ADA) and ADA level at each visit. | Up to 48 weeks. |
| Plasma drug concentration of AHB-137. | Up to 48 weeks. |
| The First Affiliated Hospital of Zhejiang University School of Medicine |
| Hangzhou |
| Zhejiang |
| China |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |