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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03568578
• Other study ID #: 2017ZX10203202002
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: June 2018
• Source: Peking University First Hospital
• Contact: Guiqiang Wang
• Phone: 13911405123
• Email: john131212[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Cirrhosis
• Liver Fibrosis

Intervention

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

Locations

Country	Name	City	State
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Guiqiang Wang	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University First hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Nanfang Hospital	Guangzhou	Guangdong
China	Zhejiang First Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	Wuxi the Fifth People's Hospital	Wuxi	Jiangsu
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-ß1,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	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.	26 weeks after liver biopsy