A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers

Peking University First Hospital450 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

450

Conditions

Hepatitis B Liver Fibrosis

Interventions

Entecavir 0.5 mgDRUG

Patients in this group will be given Entecavir 0.5 mg a day for 2 years.

Anluohuaxian Pill 12gDRUG

Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 -

Locations (18)

Guiqiang Wang

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Construct a non-invasive model based on laboratory tests

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.

Time frame: 26 weeks after liver biopsy

Secondary Outcomes

Compare the difference of fibrosis reverse rates between the two groups

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.

Time frame: 26 weeks after liver biopsy

Central Contacts

Guiqiang Wang

CONTACT

13911405123 john131212@126.com

Hong Zhao

CONTACT

13810765943 minmin2001@gmail.com

Data from ClinicalTrials.gov

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