Hepatitis B, Liver Fibrosis
Conditions
Keywords
Fibrosis, Liver Cirrhosis, non-invasive biopsy, hepatitis B virus
Brief summary
The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.
Detailed description
450 patients who are infected with hepatitis B virus for at least 6 months will be included in the study. They will be divided into two groups. One group will be treated with Entecavir while another treated with Entecavir and Anluohuaxian Pill. Liver biopsy samples and blood samples from the patients will be used to validate the non-invasive model. Furthermore, the samples will be used to evaluate if Anluohuaxian Pill could reverse liver fibrosis and cirrhosis.
Interventions
DRUGEntecavir 0.5 mg
Patients in this group will be given Entecavir 0.5 mg a day for 2 years.
DRUGAnluohuaxian Pill 12g
Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. HBsAg positive for at least 6 months 2. Agree to have liver biopsy 3. Male or female aged 18 to 70 years old -
Exclusion criteria
1. Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease, nonalcoholic liver disease or other chronic liver disease 2. Platelet count \< 80 × 10\^9/L 3. Prothrombin activity ≤ 60% 4. Decompensated liver cirrhosis 5. Patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Construct a non-invasive model based on laboratory tests | 26 weeks after liver biopsy | We will measure the following biomarkers: TIMP1，CXCL10，CD25，YKL-40，collagen IV，von Willebrand Factor，TGF-β1，ANGPTL2，MMP-9，IL-2R，PDGF-AA，PDGF-BB，TGF-a，LN，MMP-1, soluble CD163 and CXCL9. To formulate the predictive models for detecting significant fibrosis (Ishak fibrosis score ≥3)， univariate analysis was performed on variables between patients with and without significant fibrosis. The significant variables (p\<0.05) were then subjected to multivariate stepwise logistic regression, using backward approaches, and were combined using the logistic regression function. The diagnostic value of each regression model was assessed using receiver operating characteristics curves. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the difference of fibrosis reverse rates between the two groups | 26 weeks after liver biopsy | Liver biopsy samples will be evaluated by Ishak fibrosis score. Then we compare the difference of fibrosis reverse rates between the two groups by Ishak fibrosis score. |
Countries
China
Contacts
Primary ContactGuiqiang Wang
Backup ContactHong Zhao
Outcome results
None listed