Traditional Chinese Medicine Combined With Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV
NCT ID: NCT02241616
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
350 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 Traditional Chinese Medicine in refractory liver fibrosis in 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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Entecavir+Fuzheng Huayu+TCM Granule
Tablet with Entecavir+ Tablet with Fuzheng Huayu+ Granule with TCM
Entecavir+Fuzheng Huayu+TCM Granule
The subjects will be taking 1 Entecavir tablet per day, 4 Fuzheng Huayu tablets three times a day and specific Traditional Chinese Medicine granule for 48 weeks.
Interventions
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Entecavir+Fuzheng Huayu+TCM Granule
The subjects will be taking 1 Entecavir tablet per day, 4 Fuzheng Huayu tablets three times a day and specific Traditional Chinese Medicine granule for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Within 2 years of Entecavir treatment, HBV-DNA is negative but has not reach the clinical endpoint (HBeAg seroconversion or HBsAg loss in HBeAg-positive patients; HBsAg loss or anti-HBs seroconversion in HBeAg-negative patients)
* Age 18-60
* Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-fibrosis drug was taken within 6 months.
* Child-Pugh\<7 (Stage A)
* The patient or the patient's guardian agrees to participate the random controlled trial and sign the Informed Consent Form.
Exclusion Criteria
* 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 other anti-viral 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 Traditional Chinese Medicine
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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Chen Y, Zhao Z, Fan H, Li Z, He Y, Liu C. Safety and therapeutic effects of anti-fibrotic Traditional Chinese Medicine Fuzheng Huayu on persistent advanced stage fibrosis following 2 years entecavir treatment: Study protocol for a single arm clinical objective performance criteria trial. Contemp Clin Trials Commun. 2020 Jun 23;19:100601. doi: 10.1016/j.conctc.2020.100601. eCollection 2020 Sep.
Other Identifiers
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SGHLC20140818002
Identifier Type: -
Identifier Source: org_study_id
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