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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir alafenamide (TAF) | Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Alafenamide | Drug | The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of participants with HBV DNA < 20 IU/mL | proportion of participants with HBV DNA < 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with HBV DNA < 20 IU/mL | The proportion of patients with HBV DNA < 20 IU/mL at 12 months | 12 months |
| The proportion of patients with HBV DNA <300 copies/mL | The proportion of patients with HBV DNA <300 copies/mL at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Males and non-pregnant, non-lactating female patients with HBsAg positive > 6 months above 18 years of age; Documented evidence of chronic HBV infection previously; HBV mono-infected HBeAg positive or negative; NA treatment-naive and treatment-experienced; TAF naive; Agree to participate in the study and sign the patient informed consent.
Subjects coinfected with HCV, hepatitis D virus (HDV), human immunodeficiency virus (HIV) or who have received TAF or who haveChild-Pugh C decompensated liver disease or HCC will be excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Ning, MD., Ph.D. | Contact | +86 278366 2391 | qning@vip.sina.com | |
| Di Wu, MD., Ph.D. | Contact | +86 278366 2391 | woody_1984@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qin Ning, MD., Ph.D. | Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430030 | 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 |
|---|---|
| C442442 | tenofovir alafenamide |
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Serum, urine and whole blood will be restored in central lab
|
| 12 months |
| The proportion of patients with HBV DNA < 20 IU/mL | The proportion of patients with HBV DNA < 20 IU/mL at 24 months | 24 months |
| The proportion of patients with HBV DNA <300 copies/mL IU/mL | The proportion of patients with HBV DNA <300 copies/mL at 24 months | 24 months |
| The proportion of patients with HBV DNA <300 copies/mL IU/mL | The proportion of patients with HBV DNA <300 copies/mL at 36 months | 36 months |
| Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss | Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months | 36 months |
| Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) | Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months | 36 months |
| Proportion of participants with Normal Alanine Aminotransferase (ALT) | Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months | 36 months |
| Change from baseline in fibrosis as assessed by Fibroscan® | Change from baseline in fibrosis as assessed by Fibroscan® at 36 months | 36 months |
| Percent Change from baseline in Bone Mineral Density (BMD) | Percent Change from baseline in Bone Mineral Density (BMD) at 36 months | 36 months |
| Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) | Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months | 36 months |
| the rate of mother-to-child transmission of HBV | For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate | at postpartum 6 months |
| Shulan(Hangzhou) hospitai | Recruiting | Hangzhou | China |
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| First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
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| Shanghai public health clinic | Recruiting | Shanghai | China |
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| General Hospital of The Yangtze River Shipping | Not yet recruiting | Wuhan | China |
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| The Seventh Hospital of Wuhan | Recruiting | Wuhan | China |
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| Xiangya Hospital of Central South University | Recruiting | Xiangya | China |
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| 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 |