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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Longhua Hospital | OTHER |
| Shanghai Public Health Clinical Center |
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Portal hypertension is a common pathology in chronic liver disease, particularly in liver cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The basic reason for portal hypertension in HBV is the largely deposition of hepatic extracellular matrixes which causes high pressure in liver vessels. One of the most common symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate and bleeding rate of gastroesophageal varices.
The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for reverse rate of gastroesophageal varices in patients with Moderate and Severe cirrhotic portal hypertension due to hepatitis B virus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir/Carvedilol | Placebo Comparator | Tablet with Entrcavir and Carvedilol |
|
| Entecavir/Carvedilol/ Fuzheng Huayu | Experimental | Tablet with Entrcavir and Carvedilol+ Tablet with Fuzheng Huayu |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir+Carvedilol | Drug | The subjects will be taking half a Carvedilol per day at first week and one Carvedilol per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day for 96 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc | 96 weeks | |
| Grading varices | 96 weeks | |
| Incidence of liver cancer | 96 weeks | |
| Noninvasive portal hypertension index | 96 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JING LV, MD | Contact | +86-21-20256521 | liver125@126.com |
| Name | Affiliation | Role |
|---|---|---|
| CHENGHAI LIU, PHD,MD | ShuGuang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
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| OTHER_GOV |
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| Entecavir+Carvedilol+ Fuzheng Huayu | Drug | The subjects will be taking half a Carvedilol tablet per day at first week and one Carvedilol tablets per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks. |
|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | China |
|
| Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | China |
|
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |