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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Beijing YouAn Hospital | OTHER |
| Beijing Tiantan Hospital |
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Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. In view of economic development level, drug availability and lack of independent health economics evidence, the investigators are still unable to give specific guidelines for HBV related compensated liver cirrhosis in China. Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through this prospective, open-label, multicenter and nonrandomized study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Entecavir Therapy |
| |
| Group 2 | Lamivudine plus Adefovir Dipivoxil Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | 0.5mg qd |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Decompensation rate of liver cirrhosis | presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| child-pugh score | 1,2 and 3 years | |
| HBVDNA undetected | 1,2 and 3 years | |
| liver elasticity |
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Inclusion Criteria:
written informed consent
aged 18-70 years
clinical diagnosis of compensated liver cirrhosis
liver biopsy showing cirrhosis
endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
if no biopsy or endoscopy ,should meet two of the four:
Imaging(US, CT or MRI, et al) showing Surface nodularity: Echogenecity (spleen pachydiameter > 4.0cm or> 5 costal region)
PLT < 100×10 < 9 >/L,no other interpretation
ALB < 35.0 g/L, or INR > 1.3, or CHE < 5.0KU/L
HBeAg(+)with HBVDNA > 10 < 3 > IU/mL or HBeAg(-) wtih HBVDNA > 102 IU/mL
Exclusion Criteria:
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compensated HBV Related liver cirrhosis
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| Name | Affiliation | Role |
|---|---|---|
| Dong Ji Jia, Doctor | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100050 | China | ||
| Beijing 302 Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33460002 | Derived | Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18. |
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| OTHER |
| Beijing Ditan Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Beijing 302 Hospital | OTHER |
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serum,plasma and DNA
| Lamivudine plus Adefovir Dipivoxil | Drug | Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd |
|
|
| 1, 2, and 3 years |
| life quality score | 1, 2 and 3 years |
| cost-effectiveness | 1, 2 and 3 years |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Ditan Hospital | Beijing | Beijing Municipality | China |
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | China |
| Beijing YouAn Hospital | Beijing | Beijing Municipality | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| PeKing University People's Hopital | Beijing | Beijing Municipality | China |
| The First Hospital of Peking University | Beijing | Beijing Municipality | China |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| D019259 | Lamivudine |
| C106812 | adefovir dipivoxil |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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