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Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02241590
Recruitment Status : Unknown
Verified October 2018 by Liu Chenghai, ShuGuang Hospital.
Recruitment status was:  Recruiting
First Posted : September 16, 2014
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Liu Chenghai, ShuGuang Hospital

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 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 is still required and hopefully improve the efficacy of anti-virals for liver fibrotic patients with HBV, 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 liver cirrhosis due to HBV.

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.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Due to Hepatitis B Virus Drug: Entecavir + Placebo Drug: Entecavir + Fuzheng Huayu Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Assess the Efficacy and Safety of Fuzheng Huayu Combined With Entecavir in Liver Cirrhosis Patients Due to Hepatitis B Virus
Study Start Date : September 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Placebo Comparator: Entecavir + Placebo
Tablet with Entrcavir+ Tablet with starch
Drug: Entecavir + Placebo
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.

Experimental: Entecavir + Fuzheng Huayu Tablet
Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Drug: 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.




Primary Outcome Measures :
  1. Degree of liver fibrosis [ Time Frame: 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.



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

Inclusion Criteria:

  • More than 6 months history of serum positive HBsAg
  • 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:

  • Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241590


Contacts
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Contact: Chenghai Liu, PhD 8621-20256521 chenghailiu@hotmail.com

Locations
Show Show 20 study locations
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
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Study Director: Chenghai Liu, PhD ShuGuang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liu Chenghai, Professor, ShuGuang Hospital
ClinicalTrials.gov Identifier: NCT02241590    
Other Study ID Numbers: SGHLC20140818001
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes
Entecavir
Antiviral Agents
Anti-Infective Agents