Liver Cirrhosis Due to Hepatitis B Virus Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 700 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | The Fifth People's Hospital of Anyang | Anyang | Henan |
| China | Beijing Ditan Hospital Capital Medical University | Beijing | |
| China | Beijing Youan Hospital Capital Medical University | Beijing | |
| China | China-Japan Friendship Hospital | Beijing | |
| China | The First Affiliated Hospital of Hunan University of TCM | Changsha | Hunan |
| China | Huai'an No. 4 People's Hospital | Huai'an | Jiangsu |
| China | Affiliated Hospital of Shandong Univercity of TCM | Jinan | Shandong |
| China | Jingmen No.1 People's Hospital | Jingmen | Hubei |
| China | The Ninth Hospital of Nanchang | Nanchang | Jiangxi |
| China | Guangxi Ruikang Hospital | Nanning | Guangxi |
| China | Ruijin Hospital | Shanghai | |
| China | Shanghai Zhongshan Hospital | Shanghai | |
| China | ShuGuang Hospital | Shanghai | |
| China | Shenzhen Third People's Hospital | Shenzhen | |
| China | The Fifth Hospital of Shijiazhuang | Shijiazhuang | Hebei |
| China | The Fifth People's Hospital of Suzhou | Suzhou | Jiangsu |
| China | Wenzhou Central Hospital | Wenzhou | Zhejiang |
| China | Hubei Hospital of TCM | Wuhan | Hubei |
| China | Tongji Hospital | Wuhan | Hubei |
| China | Ningxia People's Hospital | Yinchuan | Ningxia |
| Lead Sponsor | Collaborator |
|---|---|
| ShuGuang Hospital | Affiliated Hospital of Shandong Univercity of TCM, Beijing Ditan Hospital, Beijing YouAn Hospital, China-Japan Friendship Hospital, Fifth Hospital of Shijiazhuang City, Guangxi Ruikang Hospital, Huai'an No. 4 People's Hospital, Hubei Hospital of Traditional Chinese Medicine, Jingmen No.1 People’s Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, Shenzhen Third People's Hospital, 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 |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Degree of liver fibrosis | 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. | 48 weeks |