Treatment of Low-grade Cirrhotic Portal Hypertension Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
NCT ID: NCT02945956
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
192 participants
INTERVENTIONAL
2018-04-05
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Entecavir
Tablet with Entrcavir
Entecavir
The subjects will be taking 1 Entecavir tablet per day for 96 weeks.
Entecavir + Fuzheng Huayu
Tablet Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Entecavir + Fuzheng Huayu
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.
Interventions
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Entecavir
The subjects will be taking 1 Entecavir tablet per day for 96 weeks.
Entecavir + Fuzheng Huayu
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.
Eligibility Criteria
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Inclusion Criteria
* Abdominal ultrasonogram or CT scan or liver-biopsy specimen indicates liver cirrhosis
* Age 18-65
* Child-Pugh\<7 (Stage A)
* Without portal hypertension（Endoscopy indicates no signs of gastroesophageal varices.）
* Low-grade of portal hypertension（Endoscopy indicates signs of gastroesophageal varices that is line shape without red wales or spots and less than 0.3cm of diameter.）
* The patient or the patient's guardian agrees to participate the random controlled trial and sign the Informed Consent Form.
Exclusion Criteria
* Decompensated cirrhosis、The Child-Pugh score≥7
* Moderate grade of portal hypertension（Endoscopy indicates signs of gastroesophageal varices that is line shape with red wales or spots and less than 0.3cm of diameter,or snake large shape without red wales or spots and less than 1.0cm of diameter.）
* Severe grade of portal hypertension（Endoscopy indicates signs of gastroesophageal varices that is catenulate/nodular shape with or without red wales or spots and more than 1.0cm of diameter.）
* Decompensated liver cirrhosis Liver cancer
* Liver histology conform to other chronic liver disease cause (exclude fatty liver)
* Non-HBV avihepadnavirus infected acute and chronic hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic hepatitis, Alcoholic liver disease.
* Have psychiatric history or uncontrollable epilepsy patient.
* Uncontrollable diabetic patient
* History of Hemoglobin disease (such as Alpha globin generation barrier anemia, Sickle cell deficiency, Spherocytosis) or Hemolytic anemia patients caused by other reasons like autoimmunity.
* Severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
* In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrow transplantation and stem cell transplantation.
* Immunocompromised patients: such as HIV infection or take immunosuppressor or glucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3 months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancer chemotherapy) and radioactive therapy.
* Gestation or lactation period women and women who plan to get pregnant during the study period.
* Patient who are allergy to the experimental drug.
* Using history of anti-viral or anti-fibrosis drug within 6 months.
* Patients who are participating other trials.
* Other situation where PI thinks the patient should be excluded.
18 Years
65 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Longhua Hospital
OTHER
Shanghai Public Health Clinical Center
OTHER_GOV
ShuGuang Hospital
OTHER
Responsible Party
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Liu Chenghai
Professor
Principal Investigators
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CHENGHAI LIU, PHD,MD
Role: PRINCIPAL_INVESTIGATOR
ShuGuang Hospital
Locations
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Ruijin Hospital
Shanghai, , China
Shanghai Zhongshan Hospital
Shanghai, , China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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hui Wang
Role: primary
Wei Jiang
Role: primary
Jing Lv
Role: primary
Other Identifiers
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SGHLC20161023003
Identifier Type: -
Identifier Source: org_study_id
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