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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| RenJi Hospital | OTHER |
| Peking University | OTHER |
| Shanghai Zhongshan Hospital |
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Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir Therapy | Active Comparator | Entecavir, 0.5mg, qd, oral, for 2 years |
|
| Entecavir plus thymosin therapy | Experimental | Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | anti-viral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decompensated rate of Liver Cirrhosis after 2 years treatment | Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Child-Pugh and MELD scores | The progress of Child-Pugh and MELD scores after 1 and 2-year treatment | 1 and 2-year |
| The HBV DNA undetectable rate | The HBV DNA undetectable rate after 1 and 2-year treatment |
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Inclusion Criteria:
Patients from age 18 to 65 years ;
Male or female;
Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions);
endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
if no endoscopy,should meet two of the four Criterias:
HBeAg-positive, HBVDNA > 2×10<3> IU/ml or with HBeAg-negative patients, HBVDNA > 2×10<2> IU/ml;
Agree to be followed up regularly;
Signature of written inform consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong You, Doctor | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Peking University First Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34843068 | Derived | Wu X, Hong J, Zhou J, Sun Y, Li L, Xie W, Piao H, Xu X, Jiang W, Feng B, Chen Y, Xu M, Cheng J, Meng T, Wang B, Chen S, Kong Y, Ou X, You H, Jia J. Health-related quality of life improves after entecavir treatment in patients with compensated HBV cirrhosis. Hepatol Int. 2021 Dec;15(6):1318-1327. doi: 10.1007/s12072-021-10240-4. Epub 2021 Nov 29. | |
| 33460002 |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| D000077596 | Thymalfasin |
| ID | Term |
|---|---|
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Public Health Clinical Center | OTHER_GOV |
| Nanfang Hospital, Southern Medical University | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Beijing YouAn Hospital | OTHER |
| Peking University First Hospital | OTHER |
| Beijing 302 Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Beijing Ditan Hospital | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Huashan Hospital | OTHER |
| Tongji Hospital | OTHER |
| Tang-Du Hospital | OTHER |
| Fifth Hospital of Shijiazhuang City | OTHER |
| Logistics University of Chinese People's Armed Police Forces | OTHER |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
| The Affiliated Hospital of Yanbian University | OTHER |
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| Thymosin-α | Drug | anti-viral and antitherapy |
|
|
| 1 and 2-year |
| Liver stiffness measurement | Liver stiffness measurement change after 1 and 2-year treatment. | 1 and 2-year |
| Quality of Life | Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares | 1 and 2-year |
| Beijing |
| Beijing Municipality |
| 100034 |
| China |
| 302 Military Hospital Of China | Beijing | Beijing Municipality | 100039 | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100050 | China |
| Beijing YouAn Hospital, Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PeKing University | Beijing | Beijing Municipality | 100871 | China |
| NanfangHospital,Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Shijiazhuang Fifth Hospital | Shijiazhuang | Hebei | 50021 | China |
| Tongji Hospital, Tongji Medical College ,Huazhong University of Science &Technology | Wuhan | Hubei | 300030 | China |
| Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University | Hangzhou | Jiangsu | 310016 | China |
| The Affiliated Hospital of Yanbian University | Yanbian | Jilin | 133000 | China |
| RenjiHospital,Shanghai Jiao Tong University,School of Medicine | Shanghai | Shanghai Municipality | 200032 | China |
| Huashan Hospital FuDan University | Shanghai | Shanghai Municipality | 200040 | China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 201508 | China |
| The First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 30001 | China |
| The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force | Tianjin | Tianjin Municipality | 300162 | China |
| 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. |
| 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 |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |