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UsingTAF as the control, the nvestigators aim to further explore the efficacy and safety of different dosages of HTS in the treatment of patients with chronic hepatitis B; ultimately, the nvestigators determine the optimal recommended dosage of HTS to provide a basis for Phase III confirmatory clinical research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTS 20mg | Experimental |
| |
| HTS 30mg | Experimental |
| |
| HTS 40mg | Experimental |
| |
| TAF 25mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTS 20mg | Drug | Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0 | through study completion, an average of 1 year |
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Inclusion Criteria:
1)Age between 18 to 65 years old (inclusive), regardless of gender. 2) Meets diagnostic criteria for chronic hepatitis B (documented HBsAg positivity or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy histopathology).
3)No prior treatment with any nucleos(t)ide analogue oral antiviral therapy; or, previous treatment with any nucleos(t)ide analogue must have ended at least 6 months prior to baseline.
4) Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit.
5) Willing to use effective non-pharmacological contraception during the trial period.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Jilin City | changchun | 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 |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| HTS 30mg | Drug | Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal. |
|
| HTS 40mg | Drug | Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal. |
|
| TAF 25mg | Drug | Once daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal. |
|
| 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 |