Trial record 122 of 435 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by ShuGuang Hospital
Sponsor:
Collaborators:
Fudan University
Ruikang Hospital
Hubei Hospital of TCM
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 Capital Medical University
Beijing Youan Hospital Capital Medical University
Information provided by (Responsible Party):
Liu Chenghai, ShuGuang Hospital
ClinicalTrials.gov Identifier:
NCT02241590
First received: September 12, 2014
Last updated: NA
Last verified: September 2014
History: No changes posted
  Purpose

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 Intervention Phase
Liver Cirrhosis Due to Hepatitis B Virus
Drug: Entecavir + Fuzheng Huayu Tablet
Drug: Entecavir + Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by ShuGuang Hospital:

Primary Outcome Measures:
  • Degree of liver fibrosis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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 reversion.


Estimated Enrollment: 700
Study Start Date: September 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Entecavir + Placebo
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
Drug: Entecavir + Placebo
Experimental: 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.
Drug: Entecavir + Fuzheng Huayu Tablet

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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 random controlled trial and sign the Informed Consent Form.

Exclusion Criteria:

  • Primary Entecavir resistance
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02241590

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

Locations
China, Hubei
Hubei Provincial Hospital of TCM Not yet recruiting
Wuhan, Hubei, China
China, Hunan
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine Not yet recruiting
Changsha, Hunan, China
China, Jiangsu
Huai'an No. 4 People's Hospital Not yet recruiting
Huai'an, Jiangsu, China
China
Beijing Ditan Hospital Capital Medical University Not yet recruiting
Beijing, China
Beijing Youan Hospital Capital Medical University Not yet recruiting
Beijing, China
Ruikang Hospital of Guangxi Traditional Chinese Medical University Not yet recruiting
Nanning, China
Ruijin Hospital Not yet recruiting
Shanghai, China
ShuanGuang Hospital Recruiting
Shanghai, China, 201203
Contact: Zhimin Zhao, PhD    +8615800581663    kilorair@sina.com   
Zhongshan Hospital Fudan University Not yet recruiting
Shanghai, China
Shenzhen Third People's Hospital Not yet recruiting
Shenzhen, China
Sponsors and Collaborators
ShuGuang Hospital
Fudan University
Ruikang Hospital
Hubei Hospital of TCM
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 Capital Medical University
Beijing Youan Hospital Capital Medical University
Investigators
Study Director: Chenghai Liu, PhD ShuGuang Hospital
  More Information

No publications provided

Responsible Party: Liu Chenghai, Professor, ShuGuang Hospital
ClinicalTrials.gov Identifier: NCT02241590     History of Changes
Other Study ID Numbers: SGHLC20140818001
Study First Received: September 12, 2014
Last Updated: September 12, 2014
Health Authority: China: Ministry of Science and Technology

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014