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This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate 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 HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.
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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 |
|---|---|---|
| Survival rate in the follow-up | Whether patients will survive after treatment is observed in the follow-up. | 144 week |
| Measure | Description | Time Frame |
|---|---|---|
| Model for end-stage liver disease (MELD) score is recorded after treatment | The calculation of model for end-stage liver disease (MELD) score is: R=0.378ln[serum total bilirubin (mg/dl)]+1.12ln(prothrombin time international normalized ratio)+0.95ln[serum creatinin(mg/dl)]+0.64. The higher the MELD score, the higher the mortality rate. MELD score is recorded after treatment. | 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39958923 | Derived | Zhang Y, Xu W, Deng Z, Wang L, Zheng X, Zhu X, Li X, Li J, Shu X, Lai J, Peng L, Xie C. Long-term efficacy and safety of tenofovir alafenamide, tenofovir disoproxil fumarate, and entecavir in treating hepatitis B virus-related acute-on-chronic liver failure: A 144-week data analysis. Liver Res. 2024 Oct 24;8(4):295-303. doi: 10.1016/j.livres.2024.10.001. eCollection 2024 Dec. |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae 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. |
|
|
| 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 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |