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

June 25, 2018 updated by: Guiqiang Wang, Peking University First Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
          • Fudong Lv
          • Phone Number: 13681547749
          • Email: lfd@tom.com
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Guiqiang Wang
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Nanfang Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The people's hospital of Guangxi Zhuang Autonomous Region
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
      • Wuxi, Jiangsu, China
        • Recruiting
        • Wuxi the Fifth People's Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Entecavir Group
Patients in this arm will be given Entecavir 0.5 mg a day for 2 years.
Drug: Entecavir 0.5 mg
Patients in this group will be given Entecavir 0.5 mg a day for 2 years.
Other Names:
  • ETV
Experimental: Entecavir and Anluohuaxian Group
Patients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years.
Drug: Entecavir 0.5 mg
Patients in this group will be given Entecavir 0.5 mg a day for 2 years.
Other Names:
  • ETV
Drug: Anluohuaxian Pill 12g
Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years
Other Names:
  • ALHX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Construct a non-invasive model based on laboratory tests
Time Frame: 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.
26 weeks after liver biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the difference of fibrosis reverse rates between the two groups
Time Frame: 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.
26 weeks after liver biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017ZX10203202002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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