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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHB-137 (16 weeks) and Peg-IFN | Experimental |
| |
| AHB-137 (24 weeks) and Peg-IFN | Experimental |
| |
| AHB-137 and Hepatitis B vaccine | Experimental |
| |
| AHB-137 | Experimental |
| |
| AHB-137 (24 weeks) and Peg-IFN(24 weeks) | Experimental | R3 group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-137 | Drug | AHB-137 will be injected. |
|
| Measure | Description | 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. | up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ . | Up to 72 weeks | |
| Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg. | Up to 72 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 |
|---|---|---|
| Jia | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing 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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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Peg-IFN | Drug | Peg-IFN will be administered . |
|
| Hepatitis B Vaccine | Drug | Hepatitis B vaccine will be administered. |
|
| Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period. | Up to 48 weeks |
| Relapse rate after discontinuation of NAs therapy. | Up to 72 weeks |
| Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values. | Up to 72 weeks |
| Relapse time after discontinuation of NAs therapy. | Up to 72 weeks |
| Plasma concentrations of AHB-137. | Up to 48 weeks |
| Serum concentrations of Peg-IFN. | Up to 48 weeks. |
| Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA). | Up to 72 weeks |
| 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. | 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. | 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. | 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. | 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. | Up to 72 weeks. |
| Discontinue all treatment for CHB for 24 weeks with HBV DNA<LLOQ and HBsAg<10IU/mL. | Up to 72 weeks |
| 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 |
| D045424 |
| Complex Mixtures |