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This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.
Hepatitis b virus infection 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 hepatitis b virus related compensated cirrhosis. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETV group | Active Comparator | 50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long. |
|
| TDF group | Active Comparator | 50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long. |
|
| TAF group | Experimental | 50 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 |
|---|---|---|
| Incidence of decompensated cirrhosis | Incidence of decompensated cirrhosis is evaluated in the follow-up | 144 week |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of patients with undetectable hepatitis b virus DNA after treatment | Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment. | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| Ratio of patients with hepatitis b virus e antigen seroconversion after treatment |
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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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| 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 virus e antigen and e antibody would be tested to know the ratio of patients with hepatitis b virus e antigen seroconversion at 7 time points after treatment. |
| 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| Ratio of patients with undetectable hepatitis b virus surface antigen after treatment | Hepatitis b virus surface antigen would be tested to know the ratio of patients with undetectable hepatitis b virus surface antigen at 7 time points after treatment. | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| Serum calcium | Hypocalcemia would be evaluated after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| Serum phosphorus | Hypophosphatemia would be evaluated after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| Blood urea nitrogen | Blood urea nitrogen would be tested after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| Serum creatinine | Serum creatinine would be tested after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| Estimated glomerular filtration rate | Estimated glomerular filtration rate would be evaluated after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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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 |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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