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Traditional Chinese Medicine Combined With Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV

Sponsor
ShuGuang Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02241616
Collaborator
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 (Other), 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), Shandong University of Traditional Chinese Medicine (Other), 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 (Other)
350
Enrollment
20
Locations
1
Arm
57
Duration (Months)
17.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of Liver cirrhosis in China. The effective inhibition of HBV can partially regress or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, however some patients keep existence or development although HBV DNA is under-detectable after anti-virals. Theses refractory liver fibrosis is required the anti-fibrotic treatment focusing on the regulation of hepatic extracellular matrix, especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis. 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 improve the reversion of refractory liver fibrosis in liver cirrhosis due to HBV.

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Entecavir+Fuzheng Huayu+TCM Granule
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center Study to Assess the Efficacy and Safety of Traditional Chinese Medicine Combined With Entecavir for Patients With Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Entecavir+Fuzheng Huayu+TCM Granule

Tablet with Entecavir+ Tablet with Fuzheng Huayu+ Granule with TCM

Drug: 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 Names:
  • Gan Ping
  • 319 Recipe
  • FZHY

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Degree of liver fibrosis [48 weeks]

      The collagen of liver tissue from 48 week post-treatment patients was stained. 3 pathologists read the slides independently and score the slides with Ishak system. If the Ishak score decrease 1 or more than 1 score, then it is recorded as regression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Hepatitis B history or more than 6 months history of positive HBsAg

    • 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:

    • 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 other anti-viral drug within 6 months.

    • Patients who are participating other trials.

    • Other situation where PI thinks the patient should be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangxi Ruikang Hospital Nanning Guangxi China
    2 The Fifth Hospital of Shijiazhuang Shijiazhuang Hebei China
    3 The Fifth People's Hospital of Anyang Anyang Henan China
    4 Jingmen No.1 People's Hospital Jingmen Hubei China
    5 Hubei Hospital of TCM Wuhan Hubei China
    6 Tongji Hospital Wuhan Hubei China
    7 The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine Changsha Hunan China
    8 Huai'an No. 4 People's Hospital Huai'an Jiangsu China
    9 The Fifth People's Hospital of Suzhou Suzhou Jiangsu China
    10 The Ninth Hospital of Nanchang Nanchang Jiangxi China
    11 Ningxia People's Hospital Yinchuan Ningxia China
    12 Affiliated Hospital of Shandong Univercity of TCM Jinan Shandong China
    13 Wenzhou Central Hospital Wenzhou Zhejiang China
    14 Beijing Ditan Hospital Capital Medical University Beijing China
    15 Beijing Youan Hospital Capital Medical University Beijing China
    16 China-Japan Friendship Hospital Beijing China
    17 ShuGuang Hospital Shanghai China 201203
    18 Ruijin Hospital Shanghai China
    19 Shanghai Zhongshan Hospital Shanghai China
    20 Shenzhen Third People's Hospital Shenzhen China

    Sponsors and Collaborators

    • ShuGuang Hospital
    • Shanghai Zhongshan Hospital
    • Guangxi Ruikang Hospital
    • Hubei Hospital of Traditional Chinese Medicine
    • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
    • Huai'an No. 4 People's Hospital
    • Ruijin Hospital
    • Shenzhen Third People's Hospital
    • Beijing Ditan Hospital
    • Beijing YouAn Hospital
    • China-Japan Friendship Hospital
    • Tongji Hospital
    • Wenzhou Central Hospital
    • Jingmen No.1 People's Hospital
    • Shandong University of Traditional Chinese Medicine
    • The Ninth Hospital of Nanchang
    • The People's Hospital of Ningxia
    • Fifth Hospital of Shijiazhuang City
    • The Fifth People's Hospital of Suzhou
    • The Fifth People's Hospital of Anyang

    Investigators

    • Study Director: Chenghai Liu, PhD, ShuGuang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liu Chenghai, Professor, ShuGuang Hospital
    ClinicalTrials.gov Identifier:
    NCT02241616
    Other Study ID Numbers:
    • SGHLC20140818002
    First Posted:
    Sep 16, 2014
    Last Update Posted:
    Oct 15, 2018
    Last Verified:
    Oct 1, 2018
    Additional relevant MeSH terms:
    Hepatitis B
    Liver Cirrhosis
    Fibrosis
    Entecavir

    Study Results

    No Results Posted as of Oct 15, 2018