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This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NrtIs | Active Comparator |
| |
| HH-003+NrtIs | Experimental |
| |
| HH-003+NrtIs+PEG-IFN-α | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs) | Drug | Subjects will receive NrtIs therapy for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with HBV DNA negativation | Week 24 | |
| Changes from baseline in serum HBsAg | From treatment start up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving maintained virologic response (MVR) | From treatment start up to 48 weeks | |
| Duration of MVR | From treatment start up to 48 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital,Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Beijing Friendship Hospital,Capital Medical University |
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| HH-003 and NrtIs | Drug | Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks. |
|
| HH-003, NrtIs and PEG-IFN-α | Drug | Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks. |
|
| Percentage of subjects with ALT normalization |
| From treatment start up to 48 weeks |
| Changes from baseline in serum HBeAg in subjects with positive HBeAg | From treatment start up to 48 weeks |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Beijing Youan Hospital,Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
| Mengchao Hepatobiliary Hospital Of Fujian Medical University | Fuzhou | Fujian | 350025 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| The Sixth Peoples Hospital Of Zhengzhou | Zhengzhou | Henan | 450006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130061 | China |
| Shandong Public Health Clinical Center | Jinan | Shandong | 250102 | China |
| ID | Term |
|---|---|
| D009705 | Nucleosides |
| ID | Term |
|---|---|
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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