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This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b
Chronic hepatitis b (CHB) remains a serious public health problem in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETV group | Experimental | 100 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long. |
|
| TDF group | Experimental | 100 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long. |
|
| TAF group | Experimental | 100 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of renal function decline | Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated. | 144 week |
| Rate of hypercalcemia | The serum calcium would be detected to know the ratio of patients with hypercalcemia. | 144 week |
| Measure | Description | Time Frame |
|---|---|---|
| hepatitis b virus(HBV) DNA undetectable rate | Hepatitis b virus DNA would not be detected if it below the upper limit of test value. | 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| hepatitis b e antigen loss rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenxiong Xu, Doctor | Contact | +8613760783281 | xwx1983@163.com | |
| Liang Peng, Doctor | Contact | +8613533978874 | pzp33@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liang Peng, Doctor | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | 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 |
|---|---|
| C413685 | entecavir |
| D000068698 | Tenofovir |
| C442442 | tenofovir alafenamide |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Tenofovir Disoproxil Fumarate | Drug | Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day. |
|
|
| Tenofovir Alafenamide | Drug | Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day. |
|
|
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
| 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| hepatitis b s antigen loss rate | Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value. | 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| hepatitis b e antigen seroconversion rate | hepatitis b e antibody would be tested to know the ratio of patients with positive hepatitis B e antibody | 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| 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 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |