Overview

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

Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ShuGuang Hospital
Collaborators:
Affiliated Hospital of Shandong Univercity of TCM
Beijing Ditan Hospital
Beijing YouAn Hospital
China-Japan Friendship Hospital
Fifth Hospital of Shijiazhuang City
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guangxi Ruikang Hospital
Huai'an No. 4 People's Hospital
Hubei Hospital of Traditional Chinese Medicine
Jingmen No.1 People's Hospital
Jingmen No.1 People’s Hospital
Ruijin Hospital
Shandong University of Traditional Chinese Medicine
Shanghai Zhongshan Hospital
Shenzhen Third People's Hospital
The Fifth People's Hospital of Anyang
The Fifth People's Hospital of Suzhou
The Fifth People’s Hospital of Anyang
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
The Ninth Hospital of Nanchang
The People's Hospital of Ningxia
Tongji Hospital
Wenzhou Central Hospital
Treatments:
Entecavir
Criteria
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.