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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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This study is a single-center, randomized, prospective, open-label Phase 2 Clinical trial to evaluate efficacy and safety of ETV and TQ-A3334 combinated with/without inhibitor of TQ-B2450 versus ETV alone in chronic hepatitis B patients. Patients were randomized to one of 3 different antiviral treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naive:ETV | Active Comparator | Entecavir 0.5 mg po daily for 24 weeks in naive patients |
|
| Naive:ETV+TQ-A3334 | Experimental | Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in naive patients |
|
| Naive:ETV+TQ-A3334+TQ-B2450 | Experimental | Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients |
|
| Experienced:ETV | Active Comparator | Entecavir 0.5 mg po daily for 24 weeks in treatment experienced patients |
|
| Experienced:ETV+TQ-A3334 | Experimental | Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in treatment experienced patients |
|
| Experienced:ETV+TQ-A3334+TQ-B2450 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETV | Drug | entecavir 0.5 mg qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HBsAg quantification at week 24 | HBsAg quantification are measured | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg loss rates at week 24 | HBsAg loss rates are measured | week 24 |
| HBsAg seroconversion rates at week 24 | HBsAg seroconversion rates are measured |
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Inclusion Criteria:
Exclusion Criteria:
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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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Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients |
|
| TQ-A3334 | Drug | TQ-A3334 po qw |
|
| TQ-B2450 | Drug | TQ-B2450 q3w iv |
|
| week 24 |
| HBeAg loss rates at week 24 | HBeAg loss rates are measured | week 24 |
| HBeAg seroconversion rates at week 24 | HBeAg seroconversion rates are measured | week 24 |
| HBV DNA<20IU/mL rates at week 24 | HBV DNA<20IU/mL rates are measured | week 24 |
| 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 |