Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
NCT ID: NCT02241590
Last Updated: 2018-10-15
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
700 participants
INTERVENTIONAL
2014-09-30
2019-06-30
Brief Summary
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The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients with liver cirrhosis due to HBV.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Entecavir + Placebo
Tablet with Entrcavir+ Tablet with starch
Entecavir + Placebo
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
Entecavir + Fuzheng Huayu Tablet
Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Entecavir + Fuzheng Huayu Tablet
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks.
Interventions
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Entecavir + Placebo
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
Entecavir + Fuzheng Huayu Tablet
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks.
Eligibility Criteria
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Inclusion Criteria
* Positive HBV-DNA
* Age 18-60
* Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-virus or anti-fibrosis drug was taken within 6 months.
* Child-Pugh\<7 (Stage A)
* The patient or the patient's guardian agrees to participate the trial and sign the informed Consent Form.
Exclusion Criteria
* Decompensated liver cirrhosis
* HCC
* Liver histology conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced liver injury, parasitic infections, alcoholic liver disease.
* Have psychiatric history or uncontrollable epilepsy patient.
* Uncontrollable diabetic patient
* History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle cell disease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.
* 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
60 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Guangxi Ruikang Hospital
OTHER
Hubei Hospital of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
Huai'an No. 4 People's Hospital
UNKNOWN
Ruijin Hospital
OTHER
Shenzhen Third People's Hospital
OTHER
Beijing Ditan Hospital
OTHER
Beijing YouAn Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Tongji Hospital
OTHER
Wenzhou Central Hospital
OTHER
Jingmen No.1 People's Hospital
OTHER
Affiliated Hospital of Shandong Univercity of TCM
UNKNOWN
The Ninth Hospital of Nanchang
OTHER
The People's Hospital of Ningxia
OTHER
Fifth Hospital of Shijiazhuang City
OTHER
The Fifth People's Hospital of Suzhou
OTHER
The Fifth People's Hospital of Anyang
UNKNOWN
ShuGuang Hospital
OTHER
Responsible Party
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Liu Chenghai
Professor
Principal Investigators
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Chenghai Liu, PhD
Role: STUDY_DIRECTOR
ShuGuang Hospital
Locations
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Guangxi Ruikang Hospital
Nanning, Guangxi, China
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
The Fifth People's Hospital of Anyang
Anyang, Henan, China
Jingmen No.1 People's Hospital
Jingmen, Hubei, China
Hubei Hospital of TCM
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Hunan University of TCM
Changsha, Hunan, China
Huai'an No. 4 People's Hospital
Huai'an, Jiangsu, China
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
The Ninth Hospital of Nanchang
Nanchang, Jiangxi, China
Ningxia People's Hospital
Yinchuan, Ningxia, China
Affiliated Hospital of Shandong Univercity of TCM
Jinan, Shandong, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Beijing Ditan Hospital Capital Medical University
Beijing, , China
Beijing Youan Hospital Capital Medical University
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
ShuGuang Hospital
Shanghai, , China
Ruijin Hospital
Shanghai, , China
Shanghai Zhongshan Hospital
Shanghai, , China
Shenzhen Third People's Hospital
Shenzhen, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Li ZX, Zhao ZM, Liu P, Zheng QS, Liu CH. Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet () and Entecavir: Design of a Randomized, Double-Blind, Parallel and Multicenter Clinical Trial. Chin J Integr Med. 2021 Jul;27(7):509-513. doi: 10.1007/s11655-020-3257-6. Epub 2020 Jun 22.
Other Identifiers
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SGHLC20140818001
Identifier Type: -
Identifier Source: org_study_id
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