Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters

Hepatitis B Clinical Trial

— HBV  

Official title:

Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962155
• Other study ID #: 2013ZX10002005
• Status: Completed
• Phase: N/A
• First received: October 5, 2013
• Last updated: September 8, 2016
• Start date: August 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis caused by hepatitis B virus in mainland China.

Description:

Up to Oct, 2015,total of 1800 patients with chronic HBV infection were enrolled. Paired blood and liver biopsy samples were collected. Blood samples stored at -80 degree Celsius. Liver biopsy samples were judged by three pathology experts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1841
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 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 65 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 < 80000/L

3. prothrombin activity = 60%

4. 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Peking University First Hospital	Bei Jing	Beijing
China	302 Military Hospital of China	Beijing	Beijing
China	Beijing Ditan Hospital	Beijing	Beijing
China	Beijing Youan Hospital, Capital Medical University	Beijing
China	China-Japan Friendship Hospital	Beijing
China	The 305 Hospital of People's Liberation Army	Beijing
China	The Second Xiangya Hospital of Central South Hospital	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu
China	Southwest Hospital, Third Military Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Dalian the Sixth People's Hospital	Dalian	Liaoning
China	Guangzhou Eighth People's Hospital	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Zhejiang First Hospital	Hang Zhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	81 Military Hospital of China	Nanjing	Jiangsu
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	The Second Hospital of Nanjing	Nanjing	Jiangsu
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	The Third People's Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	Shanghai Public Health Clinical Center	Shanghai
China	Shanghai Ruijin Hospital	Shanghai
China	The Sixth People's Hospital of Shenyang	Shenyang	Liaoning
China	The Third people's Hospital of Shenzhen	Shenzhen	Guangdong
China	Shan Xi Medical University	Taiyuan	Shanxi
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The Third Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Yantai City Hospital for Infectious Diseases	Yantai	Shandong
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	determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis B		singular evaluation at the time of liver biopsy	No