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

Primary Purpose

Hepatitis B, Liver Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Entecavir 0.5 mg
Anluohuaxian Pill 12g
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatitis B focused on measuring Fibrosis, Liver Cirrhosis, non-invasive biopsy, hepatitis B virus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Guiqiang WangRecruiting
  • Peking University First HospitalRecruiting
  • Beijing Youan Hospital, Capital Medical UniversityRecruiting
  • Beijing Youan Hospital, Capital Medical University
  • Beijing Youan Hospital, Capital Medical UniversityRecruiting
  • China-Japan Friendship HospitalRecruiting
  • Peking University First hospitalRecruiting
  • Peking University People's HospitalRecruiting
  • The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • Nanfang HospitalRecruiting
  • The People's Hospital of Guangxi Zhuang Autonomous RegionRecruiting
  • Henan Provincial People's HospitalRecruiting
  • The First Affiliated Hospital with Nanjing Medical UniversityRecruiting
  • Wuxi the Fifth People's HospitalRecruiting
  • Shanghai Public Health Clinical CenterRecruiting
  • Shanghai Ruijin HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Zhejiang First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Entecavir Group

Entecavir and Anluohuaxian Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 30, 2018
Last Updated
June 25, 2018
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03568578
Brief Title
A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers
Official Title
A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Liver Fibrosis
Keywords
Fibrosis, Liver Cirrhosis, non-invasive biopsy, hepatitis B virus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Entecavir Group
Arm Type
Active Comparator
Arm Description
Patients in this arm will be given Entecavir 0.5 mg a day for 2 years.
Arm Title
Entecavir and Anluohuaxian Group
Arm Type
Experimental
Arm Description
Patients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years.
Intervention Type
Drug
Intervention Name(s)
Entecavir 0.5 mg
Other Intervention Name(s)
ETV
Intervention Description
Patients in this group will be given Entecavir 0.5 mg a day for 2 years.
Intervention Type
Drug
Intervention Name(s)
Anluohuaxian Pill 12g
Other Intervention Name(s)
ALHX
Intervention Description
Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years
Primary Outcome Measure Information:
Title
Construct a non-invasive model based on laboratory tests
Description
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 Outcome Measure Information:
Title
Compare the difference of fibrosis reverse rates between the two groups
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HBsAg positive for at least 6 months Agree to have liver biopsy Male or female aged 18 to 70 years old - Exclusion Criteria: Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease, nonalcoholic liver disease or other chronic liver disease Platelet count < 80 × 10^9/L Prothrombin activity ≤ 60% Decompensated liver cirrhosis Patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guiqiang Wang
Phone
13911405123
Email
john131212@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Zhao
Phone
13810765943
Email
minmin2001@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guiqiang Wang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang
Phone
13911405123
Email
john131212@126.com
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhao
Phone
86-13810765942
Email
minmin2001@gmail.comc
Facility Name
Beijing Youan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghua Meng
Phone
13601398756
Email
wj5773@163.com
Facility Name
Beijing Youan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fudong Lv
Phone
13681547749
Email
lfd@tom.com
Facility Name
Beijing Youan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibin Yu
Phone
13811669802
Email
xiaobenyu2002@163.com
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anlin Ma
Phone
13910253710
Email
maanlinjc@163.com
Facility Name
Peking University First hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang
Phone
13601004423
Email
wangyanwang@126.com
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongsong Chen
Phone
13501196710
Email
chenhongsong@pkuph.edu.cn
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dazhi Zhang
Phone
86-13452382818
Email
zhangdzh@etang.com
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Fan
Phone
13143522264
Email
rongfansmu@163.com
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo Zhang
Phone
13978839646
Email
zhangguogx@hotmail.com
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Kang
Phone
13938553839
Email
13938553839@163.com
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li
Phone
13905175333
Email
dr-lijun@vip.sina.com
Facility Name
Wuxi the Fifth People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihua Huang
Phone
13601513551
Email
huanglihua@sina.com
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanqing Zhang
Phone
18916039958
Email
doctorzzqsphc@163.com
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honglian Gui
Phone
13564725017
Email
lillian_ghl@163.com
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lang Bai
Phone
18980602254
Email
pangbailang@163.com
Facility Name
Zhejiang First Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weifeng Liang
Phone
13957163061
Email
dr.liangwf@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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