Liver Cirrhosis
Conditions
Keywords
Hepatitis B, Liver Cirrhosis, Regression, Efficacy
Brief summary
Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.
Interventions
DRUGentecavir
anti-viral therapy
DRUGThymosin-α
antiviral and antifibrosis therapy
Sponsors
Peking University People's Hospital
RenJi Hospital
Peking University
Shanghai Zhongshan Hospital
Fudan University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
Nanfang Hospital, Southern Medical University
Sir Run Run Shaw Hospital
Beijing YouAn Hospital
Peking University First Hospital
Beijing 302 Hospital
Peking Union Medical College Hospital
Beijing Ditan Hospital
Beijing Tiantan Hospital
Huashan Hospital
Tongji Hospital
Tang-Du Hospital
Fifth Hospital of Shijiazhuang City
Logistics University of Chinese People's Armed Police Forces
The First Affiliated Hospital of Shanxi Medical University
The Affiliated Hospital of Yanbian University
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients from age 18 to 65 years old; 2. Male or female; 3. Treatment-naive patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) who consent to undergo liver biopsy before and after treatment; 4. Patients with HBeAg-positive, HBVDNA\>2×10\<3\>IU/ml or patients with HBeAg-negative, HBVDNA\>2×10\<2\> IU/ml； 5. Agree to be followed up regularly; 6. Signature of written informed consent.
Exclusion criteria
1. Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma; 2. Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study; 3. Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases; 4. Patients with baseline AFP level higher than 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/ml for more than three months; 5. Creatinine \>1.5×ULN; 6. Patients with other uncured malignant tumors; 7. Patients with severe diseases of heart, lung, kidney, brain, blood or other organs; 8. Patients with any other reasons not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression of HBV-induced liver cirrhosis | 1.5 to 2 years | Liver cirrhosis regression of 1 point by Ishak scoring system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child-Pugh score | 1 year and 2 years | Child-Pugh score change after 1 and 2-year treatment |
| HBVDNA undetectable rate | 1 year and 2 years | The HBVDNA undetectable rate after 1 and 2-year treatment. |
| Fibroscan value | 1 year and 2 years | Fibroscan value change after 1 and 2-year treatment |
| Life Quality | 1 year and 2 years | Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire |
Countries
China
Outcome results
None listed