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This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV intolerance to standard ETV= 0.5 mg monotherapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeksï¼› |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Alafenamide (TAF) | Drug | Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeksï¼› |
|
| Measure | Description | Time Frame |
|---|---|---|
| Main efficacy endpoint | The primary efficacy endpoint is the proportion of subjects with plasma HBV DNA levels below 20 IU/ml at Week 48. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Key secondary efficacy endpoint | The proportion of subjects with plasma HBV DNA < 20 IU/mL at Weeks 24 | Week 24 |
| Key secondary efficacy endpoint | The change from baseline in plasma HBV DNA levels at Weeks 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhang Gao | Contact | 15804303019 | 15804303019@qq.com |
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| Week 48 |
| Key secondary efficacy endpoint | The proportion of subjects with ALT normalization at Weeks 24 and 48 | Week 24 and Week 48 |
| Key secondary efficacy endpoint | The proportion of subjects with HBeAg seroconversion to anti-HBe at Weeks 48 | Week 48 |
| Key secondary efficacy endpoint | The HBV DNA maintenance rate at week 48 in ETV intolerant pts. | Week 48 |
| Key secondary efficacy endpoint | The proportion of subjects with HBsAg seroconversion to anti-HBs at Weeks 48 | Week 48 |
| Key secondary efficacy endpoint | The incidence of drug resistant mutations at Weeks 48 | Week 48 |
| ID | Term |
|---|---|
| C442442 | tenofovir alafenamide |
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